{"id":596,"date":"2024-04-22T10:40:00","date_gmt":"2024-04-22T10:40:00","guid":{"rendered":"https:\/\/avas.live\/corporate-business\/?page_id=596"},"modified":"2026-06-12T10:45:38","modified_gmt":"2026-06-12T10:45:38","slug":"cases","status":"publish","type":"page","link":"https:\/\/itamqmr.com\/en\/cases\/","title":{"rendered":"Cases"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"596\" class=\"elementor elementor-596\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-6c73b16 e-con-full e-flex e-con e-parent\" data-id=\"6c73b16\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0e30663 elementor-widget elementor-widget-template\" data-id=\"0e30663\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"template.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div 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.\/tx-port-overlay -->\n\n                        <div class=\"tx-portfolio-plus-card-content\">\n                \n                                  <h4 class=\"tx-port-title\"><a href=\"https:\/\/itamqmr.com\/en\/ca\/001\/\">Sterile Finished Dosage Form Facility Qualification<\/a><\/h4>\n                \n                                \n                                            <\/div><!-- tx-port-card-content -->\n            \n\n            <!-- Modal Portfolio Body area Start -->\n            <div class=\"modal fade bd-example-modal-lg\" id=\"txModalItem-777\" tabindex=\"-1\" role=\"dialog\" aria-hidden=\"true\">\n                <div class=\"modal-dialog modal-xl modal-dialog-centered\" role=\"document\">\n                    <div class=\"modal-content\">\n                        \n                        <div class=\"modal-header\">\n                            <button type=\"button\" class=\"close\" data-dismiss=\"modal\" aria-label=\"Close\">\n                              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                                         <!-- <\/div> -->\n                                                                             <\/div>\n                                <\/div>\n                                <div class=\"col-lg-6\">\n                                    <div class=\"text-content\">\n                                        <h3>\n                                             Sterile Finished Dosage Form Facility Qualification                                        <\/h3>\n\n                                        <p><img fetchpriority=\"high\" decoding=\"async\" width=\"553\" height=\"622\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen1-1.png\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen1-1.png 553w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen1-1-267x300.png 267w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen1-1-320x360.png 320w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen1-1-390x438.png 390w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen1-1-360x405.png 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen1-1-373x420.png 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen1-1-460x517.png 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen1-1-365x411.png 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen1-1-300x337.png 300w\" sizes=\"(max-width: 553px) 100vw, 553px\" \/><br \/>\n            Case Overview<\/p>\n<h2>\n                Sterile Finished Dosage Form Facility Qualification<br \/>\n            <\/h2>\n<p>A manufacturer specializing in sterile finished dosage forms engaged our team to lead the qualification of a newly established manufacturing facility. The scope included product technology transfer, workshop and utilities qualification, personnel training, and a comprehensive gap analysis. The proactive compliance strategy ensured full readiness for a GMP inspection by a European regulatory authority, contributing to a successful facility qualification outcome and supporting accelerated market access.<\/p>\n<p>        <!-- tx-hd-wrap --><\/p>\n<ul>\n<li>\n\t\t\t\t\t\t\t\t\t\tService Type: Consultancy &amp; Technology Transfer\n\t\t\t\t\t\t\t\t\t<\/li>\n<li>\n\t\t\t\t\t\t\t\t\t\tCategory: Sterile Medicinal Products\n\t\t\t\t\t\t\t\t\t<\/li>\n<\/ul>\n<p>            Our solutions<\/p>\n<h2>\n                we strive to be the industry leader in innovation<br \/>\n            <\/h2>\n<p>        <!-- tx-hd-wrap --><\/p>\n<h2>\n                Require:<br \/>\n                Providing high-quality products or services<br \/>\n            <\/h2>\n<p><strong>Our Solutions:<\/strong> Suspendisse potenti hasellus euismod libero in neque molestie et elementum libero maximus. Etiam in enim vestibulum suscipit sem quis molestie nibh. Donec ac lacus nec diam gravida pellentesque.<\/p>\n<p>        <!-- tx-hd-wrap --><\/p>\n<h2>\n                Require:<br \/>\n                Offering competitive pricing<br \/>\n            <\/h2>\n<p><strong>Our Solutions:<\/strong> Suspendisse potenti hasellus euismod libero in neque molestie et elementum libero maximus. Etiam in enim vestibulum suscipit sem quis molestie nibh. Donec ac lacus nec diam gravida pellentesque.<\/p>\n<p>        <!-- tx-hd-wrap --><\/p>\n<h2>\n                Require:<br \/>\n                Building strong relationships  with customers<br \/>\n            <\/h2>\n<p><strong>Our Solutions:<\/strong> Suspendisse potenti hasellus euismod libero in neque molestie et elementum libero maximus. Etiam in enim vestibulum suscipit sem quis molestie nibh. Donec ac lacus nec diam gravida pellentesque.<\/p>\n<p>        <!-- tx-hd-wrap --><br \/>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"626\" height=\"639\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-2.jpg\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-2.jpg 626w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-2-600x612.jpg 600w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-2-294x300.jpg 294w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-2-360x367.jpg 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-2-373x381.jpg 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-2-620x633.jpg 620w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-2-460x470.jpg 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-2-365x373.jpg 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-2-300x306.jpg 300w\" sizes=\"(max-width: 626px) 100vw, 626px\" \/><br \/>\n            Team<\/p>\n<h2>\n                Experts who Work on Project<br \/>\n            <\/h2>\n<p>        <!-- tx-hd-wrap --><br \/>\n                                                                    <img decoding=\"async\" width=\"308\" height=\"350\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/John-Doe.jpg\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/John-Doe.jpg 308w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/John-Doe-264x300.jpg 264w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/John-Doe-300x341.jpg 300w\" sizes=\"(max-width: 308px) 100vw, 308px\" \/>                                                            <!-- tx-profile-image --><\/p>\n<h4>John Doe<\/h4>\n<p>                                                                Advisor<br \/>\n                                <!-- tx-social-profile --><br \/>\n                            <!-- tx-profile-content --><br \/>\n                        <!-- tx-profile-container --><br \/>\n                    <!-- col-md --><br \/>\n                                                                    <img loading=\"lazy\" decoding=\"async\" width=\"308\" height=\"350\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/Dawn-Labadie.jpg\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/Dawn-Labadie.jpg 308w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/Dawn-Labadie-264x300.jpg 264w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/Dawn-Labadie-300x341.jpg 300w\" sizes=\"auto, (max-width: 308px) 100vw, 308px\" \/>                                                            <!-- tx-profile-image --><\/p>\n<h4>Kevin Stark<\/h4>\n<p>                                                                Consultant<br \/>\n                                <!-- tx-social-profile --><br \/>\n                            <!-- tx-profile-content --><br \/>\n                        <!-- tx-profile-container --><br \/>\n                    <!-- col-md --><br \/>\n                                                                    <img loading=\"lazy\" decoding=\"async\" width=\"308\" height=\"350\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/Kevin-Stark.jpg\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/Kevin-Stark.jpg 308w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/Kevin-Stark-264x300.jpg 264w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/Kevin-Stark-300x341.jpg 300w\" sizes=\"auto, (max-width: 308px) 100vw, 308px\" \/>                                                            <!-- tx-profile-image --><\/p>\n<h4>Dawn Labadie<\/h4>\n<p>                                                                Marketer<br \/>\n                                <!-- tx-social-profile --><br \/>\n                            <!-- tx-profile-content --><br \/>\n                        <!-- tx-profile-container --><br \/>\n                    <!-- col-md --><br \/>\n                                                                    <img loading=\"lazy\" decoding=\"async\" width=\"308\" height=\"350\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/Hubert-Moore.jpg\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/Hubert-Moore.jpg 308w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/Hubert-Moore-264x300.jpg 264w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/Hubert-Moore-300x341.jpg 300w\" sizes=\"auto, (max-width: 308px) 100vw, 308px\" \/>                                                            <!-- tx-profile-image --><\/p>\n<h4>Hubert Moore<\/h4>\n<p>                                                                Advisor<br \/>\n                                <!-- tx-social-profile --><br \/>\n                            <!-- tx-profile-content --><br \/>\n                        <!-- tx-profile-container --><br \/>\n                    <!-- col-md --><br \/>\n        <!-- row --><br \/>\n    <!-- tx-profile-wrap --><br \/>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img loading=\"lazy\" decoding=\"async\" width=\"532\" height=\"579\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-3.png\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-3.png 532w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-3-276x300.png 276w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-3-360x392.png 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-3-373x406.png 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-3-460x501.png 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-3-365x397.png 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/single-img-3-300x327.png 300w\" sizes=\"auto, (max-width: 532px) 100vw, 532px\" \/><br \/>\n            Final Outcome<\/p>\n<h2>\n                Through a relentless dedication to exceptional quality<br \/>\n            <\/h2>\n<p>Lorem ipsum dolor sit amet consectetur adipiscing elit sed do eiusmod tempor incididunt ut labore. Suspendisse potenti hasellus euismod libero in neque molestie et mentum libero maximus in enim vestibulum suscipit sem quis molestie nibh.<\/p>\n<p>        <!-- tx-hd-wrap --><\/p>\n<ul>\n<li>\n\t\t\t\t\t\t\t\t\t\tPellentesque blandit nibh eget egestas molestie justo diam hendrerit tortor\n\t\t\t\t\t\t\t\t\t<\/li>\n<li>\n\t\t\t\t\t\t\t\t\t\tAliquam arcu purus lacinia sed diam quis ullamcorper venenatis sem\n\t\t\t\t\t\t\t\t\t<\/li>\n<li>\n\t\t\t\t\t\t\t\t\t\tCurabitur ligula sapien tincidunt non euismod vitae posuere imperdiet leoae\n\t\t\t\t\t\t\t\t\t<\/li>\n<li>\n\t\t\t\t\t\t\t\t\t\tZullam nulla eros ultricies sit amet nonummy id imperdiet feugiat peded\n\t\t\t\t\t\t\t\t\t<\/li>\n<\/ul>\n                                    <\/div>\n                                    <!-- End of .text-content -->\n\n                                                                            <div class=\"widget\">\n                                                <div class=\"portfolio-meta\">\n\t  \t  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href=\"https:\/\/itamqmr.com\/en\/ca\/%e7%94%a8%e4%ba%8e%e5%85%a8%e7%90%83%e7%94%b3%e6%8a%a5%e7%9a%84%e4%b8%b4%e5%ba%8a%e8%af%95%e9%aa%8c%e7%89%a9%e6%96%99%e6%94%af%e6%8c%81\/\"><img decoding=\"async\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-390x438.jpg\" alt=\"\u9762\u5411\u5168\u7403\u7533\u62a5\u7684\u4e34\u5e8a\u8bd5\u9a8c\u6837\u54c1\u751f\u4ea7\" ><\/a>\n                                              \n            <\/div>\n            <!-- \/.tx-port-img -->    \n\n        <\/div>\n        <!-- .\/tx-port-overlay -->\n\n                        <div class=\"tx-portfolio-plus-card-content\">\n                \n                                  <h4 class=\"tx-port-title\"><a href=\"https:\/\/itamqmr.com\/en\/ca\/%e7%94%a8%e4%ba%8e%e5%85%a8%e7%90%83%e7%94%b3%e6%8a%a5%e7%9a%84%e4%b8%b4%e5%ba%8a%e8%af%95%e9%aa%8c%e7%89%a9%e6%96%99%e6%94%af%e6%8c%81\/\">Clinical Trial Material Manufacturing for Global Submissions<\/a><\/h4>\n                \n           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class=\"col-lg-6\">\n                                    <div class=\"portfolio-popup-thumbnail\">\n                                                                                      <!-- <div class=\"image\"> -->\n                                                 <img loading=\"lazy\" decoding=\"async\" width=\"940\" height=\"940\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711.jpg\" class=\"attachment-large size-large wp-post-image\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711.jpg 940w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-300x300.jpg 300w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-150x150.jpg 150w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-768x768.jpg 768w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-12x12.jpg 12w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-525x525.jpg 525w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-80x80.jpg 80w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-360x360.jpg 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-373x373.jpg 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-620x620.jpg 620w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-460x460.jpg 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-365x365.jpg 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-100x100.jpg 100w\" sizes=\"(max-width: 940px) 100vw, 940px\" \/>                                             <!-- <\/div> -->\n                                                                             <\/div>\n                                <\/div>\n                                <div class=\"col-lg-6\">\n                                    <div class=\"text-content\">\n                                        <h3>\n                                             Clinical Trial Material Manufacturing for Global Submissions                                        <\/h3>\n\n                                        <p><img loading=\"lazy\" decoding=\"async\" width=\"553\" height=\"622\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen2.png\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen2.png 553w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen2-267x300.png 267w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen2-320x360.png 320w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen2-390x438.png 390w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen2-360x405.png 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen2-373x420.png 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen2-460x517.png 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen2-365x411.png 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen2-300x337.png 300w\" sizes=\"auto, (max-width: 553px) 100vw, 553px\" \/><br \/>\n            Case Overview<\/p>\n<h2>\n                Global Clinical Trial &amp; Regulatory Strategy for Novel Biologic<br \/>\n            <\/h2>\n<p>A biotechnology company required end-to-end support for its Investigational Medicinal Product (IMP) intended for pivotal Phase III trials in Europe while being manufactured in a third country. We executed a comprehensive EU QP GMP audit of the overseas site, verifying compliance with EU and international standards. Following trial completion, we provided strategic consultancy for the U.S. FDA Biologics License Application (BLA), leveraging robust European clinical data to streamline regulatory approval pathways.<\/p>\n<p>        <!-- tx-hd-wrap --><\/p>\n<ul>\n<li>\n\t\t\t\t\t\t\t\t\t\tService Type:  Auditing &amp; Consultancy\n\t\t\t\t\t\t\t\t\t<\/li>\n<li>\n\t\t\t\t\t\t\t\t\t\tCategory:  Biologics \/ Cell Therapy\n\t\t\t\t\t\t\t\t\t<\/li>\n<\/ul>\n                                    <\/div>\n                                    <!-- End of .text-content -->\n\n                                                                            <div class=\"widget\">\n                                                <div class=\"portfolio-meta\">\n\t  \t    \t<div class=\"portfolio-author\">\n    \t\t<span><h5><i class=\"bi bi-person-circle\"><\/i>  Created By<\/h5><\/span>\n    \t\tqizhinet    \t<\/div>\n  \t\t    <\/div>\n\n                                        <\/div>\n                                    \n                                    \n                                <\/div>\n                            <\/div>\n                            <!-- End of .row Body-->\n                        <\/div>\n                    <\/div>\n                <\/div>\n            <\/div>\n            <!-- End Modal Portfolio area -->\n\n        <\/div><!-- \/.tx-portfolio-item -->\n\n        \n    <div class=\"tx-portfolio-item \u6848\u4f8b card-v\">\n        \n        <div class=\"tx-port-overlay\"> \n            \n            <div class=\"tx-port-img\">\n              \n                              \n              \n              \n                            \n                                                  <a href=\"https:\/\/itamqmr.com\/en\/ca\/%e9%9d%a2%e5%90%91%e5%9b%bd%e9%99%85%e5%b8%82%e5%9c%ba%e7%9a%84-api-%e7%94%9f%e4%ba%a7%e6%94%af%e6%8c%81\/\"><img decoding=\"async\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-390x438.jpg\" alt=\"\u539f\u6599\u836f\u6d77\u5916\u5546\u4e1a\u5316\u914d\u5957\u670d\u52a1\" ><\/a>\n                                              \n            <\/div>\n            <!-- \/.tx-port-img -->    \n\n        <\/div>\n        <!-- .\/tx-port-overlay -->\n\n                        <div class=\"tx-portfolio-plus-card-content\">\n                \n                                  <h4 class=\"tx-port-title\"><a href=\"https:\/\/itamqmr.com\/en\/ca\/%e9%9d%a2%e5%90%91%e5%9b%bd%e9%99%85%e5%b8%82%e5%9c%ba%e7%9a%84-api-%e7%94%9f%e4%ba%a7%e6%94%af%e6%8c%81\/\">API Manufacturing for International Markets<\/a><\/h4>\n                \n                                \n                                            <\/div><!-- tx-port-card-content -->\n            \n\n            <!-- Modal Portfolio Body area Start -->\n            <div class=\"modal fade bd-example-modal-lg\" id=\"txModalItem-786\" tabindex=\"-1\" role=\"dialog\" aria-hidden=\"true\">\n                <div class=\"modal-dialog modal-xl modal-dialog-centered\" role=\"document\">\n                    <div class=\"modal-content\">\n                        \n                        <div class=\"modal-header\">\n                            <button type=\"button\" class=\"close\" data-dismiss=\"modal\" aria-label=\"Close\">\n                                 <span aria-hidden=\"true\"> <i class=\"bi bi-x-circle\"><\/i><\/span>\n                            <\/button>\n                        <\/div>\n                        \n                        <div class=\"modal-body\">\n                            <div class=\"row\">\n                                <div class=\"col-lg-6\">\n                                    <div class=\"portfolio-popup-thumbnail\">\n                                                                                      <!-- <div class=\"image\"> -->\n                                                 <img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-1024x683.jpg\" class=\"attachment-large size-large wp-post-image\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-1024x683.jpg 1024w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-300x200.jpg 300w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-768x512.jpg 768w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-150x100.jpg 150w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-360x240.jpg 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-373x249.jpg 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-620x413.jpg 620w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-460x307.jpg 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-365x243.jpg 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-1000x667.jpg 1000w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-1500x1000.jpg 1500w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3.jpg 1536w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>                                             <!-- <\/div> -->\n                                                                             <\/div>\n                                <\/div>\n                                <div class=\"col-lg-6\">\n                                    <div class=\"text-content\">\n                                        <h3>\n                                             API Manufacturing for International Markets                                        <\/h3>\n\n                                        <p><img loading=\"lazy\" decoding=\"async\" width=\"553\" height=\"622\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen3.png\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen3.png 553w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen3-267x300.png 267w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen3-320x360.png 320w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen3-390x438.png 390w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen3-360x405.png 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen3-373x420.png 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen3-460x517.png 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen3-365x411.png 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen3-300x337.png 300w\" sizes=\"auto, (max-width: 553px) 100vw, 553px\" \/><br \/>\n            Case Overview<\/p>\n<h2>\n                API Manufacturing for Global Clinical Supply<br \/>\n            <\/h2>\n<p>An API manufacturer sought to supply key intermediates for Investigational New Drugs (INDs) to both the U.S. and EU markets. We commenced with a GAP analysis and full Quality System assessment, followed by a Manufacturing Process Risk Assessment to identify Critical Process Parameters (CPPs). Personnel training, qualification, and validation activities were implemented to bring the facility to required standards, culminating in GMP compliance and regulatory approvals for both target markets.<\/p>\n<p>        <!-- tx-hd-wrap --><\/p>\n<ul>\n<li>\n\t\t\t\t\t\t\t\t\t\tService Type:  Consultancy &amp; Auditing\n\t\t\t\t\t\t\t\t\t<\/li>\n<li>\n\t\t\t\t\t\t\t\t\t\tCategory:  Chemical Process \/ API\n\t\t\t\t\t\t\t\t\t<\/li>\n<\/ul>\n                                    <\/div>\n                                    <!-- End of .text-content -->\n\n                                                                            <div class=\"widget\">\n                                                <div class=\"portfolio-meta\">\n\t  \t    \t<div class=\"portfolio-author\">\n    \t\t<span><h5><i class=\"bi bi-person-circle\"><\/i>  Created By<\/h5><\/span>\n    \t\tqizhinet    \t<\/div>\n  \t\t    <\/div>\n\n                                        <\/div>\n                                 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alt=\"\u751f\u7269\u5b89\u5168\u5b9e\u9a8c\u5ba4\u5408\u89c4\u5efa\u8bbe\" ><\/a>\n                                              \n            <\/div>\n            <!-- \/.tx-port-img -->    \n\n        <\/div>\n        <!-- .\/tx-port-overlay -->\n\n                        <div class=\"tx-portfolio-plus-card-content\">\n                \n                                  <h4 class=\"tx-port-title\"><a href=\"https:\/\/itamqmr.com\/en\/ca\/%e7%94%9f%e7%89%a9%e5%ae%89%e5%85%a8%e6%a3%80%e6%b5%8b%e5%ae%9e%e9%aa%8c%e5%ae%a4%e5%90%88%e8%a7%84%e6%94%af%e6%8c%81\/\">Biosafety Testing Laboratory Compliance<\/a><\/h4>\n                \n                                \n                                            <\/div><!-- tx-port-card-content -->\n            \n\n            <!-- Modal Portfolio Body area Start -->\n            <div class=\"modal fade bd-example-modal-lg\" id=\"txModalItem-790\" tabindex=\"-1\" role=\"dialog\" aria-hidden=\"true\">\n                <div class=\"modal-dialog modal-xl modal-dialog-centered\" role=\"document\">\n                    <div class=\"modal-content\">\n                        \n                        <div class=\"modal-header\">\n                            <button type=\"button\" class=\"close\" data-dismiss=\"modal\" aria-label=\"Close\">\n                                 <span aria-hidden=\"true\"> <i class=\"bi bi-x-circle\"><\/i><\/span>\n                            <\/button>\n                        <\/div>\n                        \n                        <div class=\"modal-body\">\n                            <div class=\"row\">\n                                <div class=\"col-lg-6\">\n                                    <div class=\"portfolio-popup-thumbnail\">\n                                                                                      <!-- <div class=\"image\"> -->\n                                                 <img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"683\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-1024x683.jpg\" class=\"attachment-large size-large wp-post-image\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-1024x683.jpg 1024w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-300x200.jpg 300w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-768x512.jpg 768w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-150x100.jpg 150w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-360x240.jpg 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-373x249.jpg 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-620x413.jpg 620w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-460x307.jpg 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-365x243.jpg 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-1000x667.jpg 1000w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-1500x1000.jpg 1500w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4.jpg 1536w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>                                             <!-- <\/div> -->\n                                                                             <\/div>\n                                <\/div>\n                                <div class=\"col-lg-6\">\n                                    <div class=\"text-content\">\n                                        <h3>\n                                             Biosafety Testing Laboratory Compliance                                        <\/h3>\n\n                                        <p><img loading=\"lazy\" decoding=\"async\" width=\"553\" height=\"622\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen4.png\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen4.png 553w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen4-267x300.png 267w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen4-320x360.png 320w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen4-390x438.png 390w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen4-360x405.png 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen4-373x420.png 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen4-460x517.png 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen4-365x411.png 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen4-300x337.png 300w\" sizes=\"auto, (max-width: 553px) 100vw, 553px\" \/><br \/>\n            Case Overview<\/p>\n<h2>\n                Biosafety Testing Laboratory GMP Compliance &amp; Validation<br \/>\n            <\/h2>\n<p>A specialized biosafety testing laboratory required validation of its processes and systems to support biological drug development. We conducted a thorough EU QP GMP audit, evaluating operational controls, containment measures, equipment qualification, and data governance. Post-audit CAPA implementation strengthened data integrity, optimized workflows, and aligned procedures with rigorous global biosafety and GMP requirements.<\/p>\n<p>        <!-- tx-hd-wrap --><\/p>\n<ul>\n<li>\n\t\t\t\t\t\t\t\t\t\tService Type:  Auditing &amp; Consultancy\n\t\t\t\t\t\t\t\t\t<\/li>\n<li>\n\t\t\t\t\t\t\t\t\t\tCategory:  Biosafety Testing\n\t\t\t\t\t\t\t\t\t<\/li>\n<\/ul>\n                                    <\/div>\n                                    <!-- End of .text-content -->\n\n                                                                            <div class=\"widget\">\n                                                <div class=\"portfolio-meta\">\n\t  \t    \t<div class=\"portfolio-author\">\n    \t\t<span><h5><i class=\"bi bi-person-circle\"><\/i>  Created By<\/h5><\/span>\n    \t\tqizhinet    \t<\/div>\n  \t\t    <\/div>\n\n                                        <\/div>\n                                    \n                                    \n         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alt=\"\u65e0\u83cc\u539f\u6599\u836f\u53ca\u5236\u5242\u4e0a\u5e02\u8bb8\u53ef\u7533\u62a5\" ><\/a>\n                                              \n            <\/div>\n            <!-- \/.tx-port-img -->    \n\n        <\/div>\n        <!-- .\/tx-port-overlay -->\n\n                        <div class=\"tx-portfolio-plus-card-content\">\n                \n                                  <h4 class=\"tx-port-title\"><a href=\"https:\/\/itamqmr.com\/en\/ca\/%e6%97%a0%e8%8f%8c-api-%e4%b8%8e%e5%88%b6%e5%89%82%e7%9a%84%e4%b8%8a%e5%b8%82%e8%ae%b8%e5%8f%af%e6%94%af%e6%8c%81\/\">Sterile API and Finished Dosage Form Market Authorization<\/a><\/h4>\n                \n                                \n                                            <\/div><!-- tx-port-card-content -->\n            \n\n            <!-- Modal Portfolio Body area Start -->\n            <div class=\"modal fade bd-example-modal-lg\" id=\"txModalItem-792\" tabindex=\"-1\" role=\"dialog\" aria-hidden=\"true\">\n           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height=\"300\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case5.jpg\" class=\"attachment-large size-large wp-post-image\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case5.jpg 450w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case5-300x200.jpg 300w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case5-150x100.jpg 150w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case5-360x240.jpg 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case5-373x249.jpg 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case5-365x243.jpg 365w\" sizes=\"(max-width: 450px) 100vw, 450px\" \/>                                             <!-- <\/div> -->\n                                                                             <\/div>\n                                <\/div>\n                                <div class=\"col-lg-6\">\n                                    <div class=\"text-content\">\n                                        <h3>\n                                             Sterile API and Finished Dosage Form Market Authorization                                        <\/h3>\n\n                                        <p><img loading=\"lazy\" decoding=\"async\" width=\"553\" height=\"622\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen5.png\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen5.png 553w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen5-267x300.png 267w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen5-320x360.png 320w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen5-390x438.png 390w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen5-360x405.png 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen5-373x420.png 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen5-460x517.png 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen5-365x411.png 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen5-300x337.png 300w\" sizes=\"auto, (max-width: 553px) 100vw, 553px\" \/><br \/>\n            Case Overview<\/p>\n<h2>\n                Sterile API GMP Certification for UK &amp; EU Markets<br \/>\n            <\/h2>\n<p>An API manufacturer producing sterile active ingredients required MHRA GMP certification to supply the European market. Our engagement included a comprehensive audit of workshop and utilities qualification, a detailed GAP analysis benchmarking against MHRA expectations, and expert guidance on cleaning validation for a multipurpose sterile API plant. Successful audit outcomes secured the necessary GMP certificate.<\/p>\n<p>        <!-- tx-hd-wrap --><\/p>\n<ul>\n<li>\n\t\t\t\t\t\t\t\t\t\tService Type:  Consultancy\n\t\t\t\t\t\t\t\t\t<\/li>\n<li>\n\t\t\t\t\t\t\t\t\t\tCategory:  Sterile API &amp; Finished Dosage Forms\n\t\t\t\t\t\t\t\t\t<\/li>\n<\/ul>\n                                    <\/div>\n                                    <!-- End of .text-content -->\n\n                                                                            <div class=\"widget\">\n                                                <div class=\"portfolio-meta\">\n\t  \t    \t<div class=\"portfolio-author\">\n    \t\t<span><h5><i class=\"bi bi-person-circle\"><\/i>  Created By<\/h5><\/span>\n    \t\tqizhinet    \t<\/div>\n  \t\t    <\/div>\n\n                                        <\/div>\n                                    \n                                    \n                                <\/div>\n                            <\/div>\n                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srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-1024x558.jpg 1024w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-300x163.jpg 300w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-768x419.jpg 768w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-360x196.jpg 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-373x203.jpg 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-620x338.jpg 620w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-460x251.jpg 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-365x199.jpg 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-1000x545.jpg 1000w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7.jpg 1312w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>                                             <!-- <\/div> -->\n                                                                             <\/div>\n                                <\/div>\n                                <div class=\"col-lg-6\">\n                                    <div class=\"text-content\">\n                                        <h3>\n                                             Advanced Therapy Medicinal Products (ATMP) Support                                        <\/h3>\n\n                                        <p><img loading=\"lazy\" decoding=\"async\" width=\"553\" height=\"622\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen7.png\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen7.png 553w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen7-267x300.png 267w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen7-320x360.png 320w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen7-390x438.png 390w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen7-360x405.png 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen7-373x420.png 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen7-460x517.png 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen7-365x411.png 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/casen7-300x337.png 300w\" sizes=\"auto, (max-width: 553px) 100vw, 553px\" \/><br \/>\n            Case Overview<\/p>\n<h2>\n                Specialized QA Support for Advanced Therapy Medicinal Products (ATMPs)<br \/>\n            <\/h2>\n<p>A developer of plasmids, lentiviral vectors, and cell-based therapies (CART\/TCRT) required specialized QA support. We performed a detailed EU QP GMP audit of their ATMP manufacturing processes, followed by enhancement of their Quality Management System to address the unique challenges of gene and cell therapy production, ensuring alignment with evolving EMA guidelines.<\/p>\n<p>        <!-- tx-hd-wrap --><\/p>\n<ul>\n<li>\n\t\t\t\t\t\t\t\t\t\tService Type:  Auditing &amp; Consultancy\n\t\t\t\t\t\t\t\t\t<\/li>\n<li>\n\t\t\t\t\t\t\t\t\t\tCategory:  Cell Therapy\n\t\t\t\t\t\t\t\t\t<\/li>\n<\/ul>\n                                    <\/div>\n                                    <!-- End of .text-content -->\n\n                                                                            <div class=\"widget\">\n                                                <div class=\"portfolio-meta\">\n\t  \t    \t<div class=\"portfolio-author\">\n    \t\t<span><h5><i class=\"bi bi-person-circle\"><\/i>  Created By<\/h5><\/span>\n    \t\tqizhinet    \t<\/div>\n  \t\t    <\/div>\n\n                                       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status-publish has-post-thumbnail hentry portfolio-category-case\" role=\"listitem\">\r\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/itamqmr.com\/en\/ca\/001\/\" tabindex=\"-1\" >\r\n\t\t\t<div class=\"elementor-post__thumbnail\"><img loading=\"lazy\" decoding=\"async\" width=\"940\" height=\"940\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724710.jpg\" class=\"attachment-full size-full wp-image-2936\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724710.jpg 940w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724710-300x300.jpg 300w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724710-150x150.jpg 150w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724710-768x768.jpg 768w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724710-12x12.jpg 12w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724710-525x525.jpg 525w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724710-80x80.jpg 80w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724710-360x360.jpg 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724710-373x373.jpg 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724710-620x620.jpg 620w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724710-460x460.jpg 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724710-365x365.jpg 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724710-100x100.jpg 100w\" sizes=\"(max-width: 940px) 100vw, 940px\" \/><\/div>\r\n\t\t<\/a>\r\n\t\t\t\t<div class=\"elementor-post__text\">\r\n\t\t\t\t<h3 class=\"elementor-post__title\">\r\n\t\t\t<a href=\"https:\/\/itamqmr.com\/en\/ca\/001\/\" >\r\n\t\t\t\tSterile Finished Dosage Form Facility Qualification\t\t\t<\/a>\r\n\t\t<\/h3>\r\n\t\t\t\t<div class=\"elementor-post__excerpt\">\r\n\t\t\t<p class=\"tx-excerpt\">End-to-end qualification and validation of sterile manufacturing facilities to meet EU, FDA, and WHO GMP requirements. <\/p>\t\t<\/div>\r\n\t\t\t\t<\/div>\r\n\t\t\t\t<\/article>\r\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-788 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio-category-case\" role=\"listitem\">\r\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/itamqmr.com\/en\/ca\/%e7%94%a8%e4%ba%8e%e5%85%a8%e7%90%83%e7%94%b3%e6%8a%a5%e7%9a%84%e4%b8%b4%e5%ba%8a%e8%af%95%e9%aa%8c%e7%89%a9%e6%96%99%e6%94%af%e6%8c%81\/\" tabindex=\"-1\" >\r\n\t\t\t<div class=\"elementor-post__thumbnail\"><img loading=\"lazy\" decoding=\"async\" width=\"940\" height=\"940\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711.jpg\" class=\"attachment-full size-full wp-image-2937\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711.jpg 940w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-300x300.jpg 300w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-150x150.jpg 150w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-768x768.jpg 768w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-12x12.jpg 12w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-525x525.jpg 525w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-80x80.jpg 80w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-360x360.jpg 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-373x373.jpg 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-620x620.jpg 620w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-460x460.jpg 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-365x365.jpg 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/\u56fe\u724711-100x100.jpg 100w\" sizes=\"(max-width: 940px) 100vw, 940px\" \/><\/div>\r\n\t\t<\/a>\r\n\t\t\t\t<div class=\"elementor-post__text\">\r\n\t\t\t\t<h3 class=\"elementor-post__title\">\r\n\t\t\t<a href=\"https:\/\/itamqmr.com\/en\/ca\/%e7%94%a8%e4%ba%8e%e5%85%a8%e7%90%83%e7%94%b3%e6%8a%a5%e7%9a%84%e4%b8%b4%e5%ba%8a%e8%af%95%e9%aa%8c%e7%89%a9%e6%96%99%e6%94%af%e6%8c%81\/\" >\r\n\t\t\t\tClinical Trial Material Manufacturing for Global Submissions\t\t\t<\/a>\r\n\t\t<\/h3>\r\n\t\t\t\t<div class=\"elementor-post__excerpt\">\r\n\t\t\t<p class=\"tx-excerpt\">GMP-compliant production of investigational medicinal products for multinational clinical trials, aligned with CTD\/ICH standards. <\/p>\t\t<\/div>\r\n\t\t\t\t<\/div>\r\n\t\t\t\t<\/article>\r\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-786 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio-category-case\" role=\"listitem\">\r\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/itamqmr.com\/en\/ca\/%e9%9d%a2%e5%90%91%e5%9b%bd%e9%99%85%e5%b8%82%e5%9c%ba%e7%9a%84-api-%e7%94%9f%e4%ba%a7%e6%94%af%e6%8c%81\/\" tabindex=\"-1\" >\r\n\t\t\t<div class=\"elementor-post__thumbnail\"><img loading=\"lazy\" decoding=\"async\" width=\"1536\" height=\"1024\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3.jpg\" class=\"attachment-full size-full wp-image-2074\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3.jpg 1536w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-300x200.jpg 300w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-1024x683.jpg 1024w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-768x512.jpg 768w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-150x100.jpg 150w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-360x240.jpg 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-373x249.jpg 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-620x413.jpg 620w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-460x307.jpg 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-365x243.jpg 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-1000x667.jpg 1000w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case3-1500x1000.jpg 1500w\" sizes=\"(max-width: 1536px) 100vw, 1536px\" \/><\/div>\r\n\t\t<\/a>\r\n\t\t\t\t<div class=\"elementor-post__text\">\r\n\t\t\t\t<h3 class=\"elementor-post__title\">\r\n\t\t\t<a href=\"https:\/\/itamqmr.com\/en\/ca\/%e9%9d%a2%e5%90%91%e5%9b%bd%e9%99%85%e5%b8%82%e5%9c%ba%e7%9a%84-api-%e7%94%9f%e4%ba%a7%e6%94%af%e6%8c%81\/\" >\r\n\t\t\t\tAPI Manufacturing for International Markets\t\t\t<\/a>\r\n\t\t<\/h3>\r\n\t\t\t\t<div class=\"elementor-post__excerpt\">\r\n\t\t\t<p class=\"tx-excerpt\">Technology transfer, process validation, and regulatory readiness for Active Pharmaceutical Ingredient supply to global regulators. <\/p>\t\t<\/div>\r\n\t\t\t\t<\/div>\r\n\t\t\t\t<\/article>\r\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-790 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio-category-case\" role=\"listitem\">\r\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/itamqmr.com\/en\/ca\/%e7%94%9f%e7%89%a9%e5%ae%89%e5%85%a8%e6%a3%80%e6%b5%8b%e5%ae%9e%e9%aa%8c%e5%ae%a4%e5%90%88%e8%a7%84%e6%94%af%e6%8c%81\/\" tabindex=\"-1\" >\r\n\t\t\t<div class=\"elementor-post__thumbnail\"><img loading=\"lazy\" decoding=\"async\" width=\"1536\" height=\"1024\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4.jpg\" class=\"attachment-full size-full wp-image-2076\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4.jpg 1536w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-300x200.jpg 300w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-1024x683.jpg 1024w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-768x512.jpg 768w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-150x100.jpg 150w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-360x240.jpg 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-373x249.jpg 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-620x413.jpg 620w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-460x307.jpg 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-365x243.jpg 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-1000x667.jpg 1000w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case4-1500x1000.jpg 1500w\" sizes=\"(max-width: 1536px) 100vw, 1536px\" \/><\/div>\r\n\t\t<\/a>\r\n\t\t\t\t<div class=\"elementor-post__text\">\r\n\t\t\t\t<h3 class=\"elementor-post__title\">\r\n\t\t\t<a href=\"https:\/\/itamqmr.com\/en\/ca\/%e7%94%9f%e7%89%a9%e5%ae%89%e5%85%a8%e6%a3%80%e6%b5%8b%e5%ae%9e%e9%aa%8c%e5%ae%a4%e5%90%88%e8%a7%84%e6%94%af%e6%8c%81\/\" >\r\n\t\t\t\tBiosafety Testing Laboratory Compliance\t\t\t<\/a>\r\n\t\t<\/h3>\r\n\t\t\t\t<div class=\"elementor-post__excerpt\">\r\n\t\t\t<p class=\"tx-excerpt\">Alignment of laboratory operations with international biosafety and containment standards, including OECD GLP and GMP integration. <\/p>\t\t<\/div>\r\n\t\t\t\t<\/div>\r\n\t\t\t\t<\/article>\r\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-792 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio-category-case\" role=\"listitem\">\r\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/itamqmr.com\/en\/ca\/%e6%97%a0%e8%8f%8c-api-%e4%b8%8e%e5%88%b6%e5%89%82%e7%9a%84%e4%b8%8a%e5%b8%82%e8%ae%b8%e5%8f%af%e6%94%af%e6%8c%81\/\" tabindex=\"-1\" >\r\n\t\t\t<div class=\"elementor-post__thumbnail\"><img loading=\"lazy\" decoding=\"async\" width=\"450\" height=\"300\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case5.jpg\" class=\"attachment-full size-full wp-image-2078\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case5.jpg 450w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case5-300x200.jpg 300w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case5-150x100.jpg 150w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case5-360x240.jpg 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case5-373x249.jpg 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case5-365x243.jpg 365w\" sizes=\"(max-width: 450px) 100vw, 450px\" \/><\/div>\r\n\t\t<\/a>\r\n\t\t\t\t<div class=\"elementor-post__text\">\r\n\t\t\t\t<h3 class=\"elementor-post__title\">\r\n\t\t\t<a href=\"https:\/\/itamqmr.com\/en\/ca\/%e6%97%a0%e8%8f%8c-api-%e4%b8%8e%e5%88%b6%e5%89%82%e7%9a%84%e4%b8%8a%e5%b8%82%e8%ae%b8%e5%8f%af%e6%94%af%e6%8c%81\/\" >\r\n\t\t\t\tSterile API and Finished Dosage Form Market Authorization\t\t\t<\/a>\r\n\t\t<\/h3>\r\n\t\t\t\t<div class=\"elementor-post__excerpt\">\r\n\t\t\t<p class=\"tx-excerpt\">Strategic support for EU MAA, FDA NDA, and other global marketing authorization pathways. <\/p>\t\t<\/div>\r\n\t\t\t\t<\/div>\r\n\t\t\t\t<\/article>\r\n\t\t\t\t<article class=\"elementor-post elementor-grid-item post-796 portfolio type-portfolio status-publish has-post-thumbnail hentry portfolio-category-case\" role=\"listitem\">\r\n\t\t\t\t<a class=\"elementor-post__thumbnail__link\" href=\"https:\/\/itamqmr.com\/en\/ca\/%e5%85%88%e8%bf%9b%e6%b2%bb%e7%96%97%e8%8d%af%e7%89%a9%ef%bc%88atmp%ef%bc%89%e6%94%af%e6%8c%81\/\" tabindex=\"-1\" >\r\n\t\t\t<div class=\"elementor-post__thumbnail\"><img loading=\"lazy\" decoding=\"async\" width=\"1312\" height=\"715\" src=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7.jpg\" class=\"attachment-full size-full wp-image-2082\" alt=\"\" srcset=\"https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7.jpg 1312w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-300x163.jpg 300w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-1024x558.jpg 1024w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-768x419.jpg 768w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-360x196.jpg 360w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-373x203.jpg 373w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-620x338.jpg 620w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-460x251.jpg 460w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-365x199.jpg 365w, https:\/\/itamqmr.com\/wp-content\/uploads\/2024\/04\/case7-1000x545.jpg 1000w\" sizes=\"(max-width: 1312px) 100vw, 1312px\" \/><\/div>\r\n\t\t<\/a>\r\n\t\t\t\t<div class=\"elementor-post__text\">\r\n\t\t\t\t<h3 class=\"elementor-post__title\">\r\n\t\t\t<a href=\"https:\/\/itamqmr.com\/en\/ca\/%e5%85%88%e8%bf%9b%e6%b2%bb%e7%96%97%e8%8d%af%e7%89%a9%ef%bc%88atmp%ef%bc%89%e6%94%af%e6%8c%81\/\" >\r\n\t\t\t\tAdvanced Therapy Medicinal Products (ATMP) Support\t\t\t<\/a>\r\n\t\t<\/h3>\r\n\t\t\t\t<div class=\"elementor-post__excerpt\">\r\n\t\t\t<p class=\"tx-excerpt\">Regulatory, quality, and compliance solutions for cell and gene therapies, tissue-engineered products, and ATMP classification. <\/p>\t\t<\/div>\r\n\t\t\t\t<\/div>\r\n\t\t\t\t<\/article>\r\n\t\t\t\t<\/div>\r\n\t\t\t\t\t<span class=\"e-load-more-spinner\">\r\n\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-spinner\" viewbox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M304 48c0 26.51-21.49 48-48 48s-48-21.49-48-48 21.49-48 48-48 48 21.49 48 48zm-48 368c-26.51 0-48 21.49-48 48s21.49 48 48 48 48-21.49 48-48-21.49-48-48-48zm208-208c-26.51 0-48 21.49-48 48s21.49 48 48 48 48-21.49 48-48-21.49-48-48-48zM96 256c0-26.51-21.49-48-48-48S0 229.49 0 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