MQMR SOLUTIONS Srl.

European QP & Regulatory Partner Supporting Chinese Pharmaceutical Companies in Global Expansion

Empowering Chinese pharmaceutical companies in their global journey, we provide the expertise of a dedicated European Qualified Person (QP). Our adaptive, responsive, and value-driven compliance solutions support efficient market access preparation and regulatory excellence.

Tailored Strategies | Swift Execution | Optimized Value

Learn more

Advancing Global Market Access for Chinese Pharmaceutical Enterprises Through Regulatory Excellence

We deliver comprehensive insights into the complex policy landscapes and regulatory divergences between China and the EU, addressing critical market entry barriers and localization challenges. By identifying strategic opportunities, we provide actionable guidance to support the development of tailored, compliant market expansion strategies, aligned with both NMPA and international regulatory frameworks.

Learn more

MQMR Solutions

is a globally focused consultancy specializing in pharmaceutical Good Manufacturing Practice (GMP) compliance and regulatory registration. We provide comprehensive, end-to-end compliance solutions spanning the entire product lifecycle—from early-stage research and development through to commercialization. With strategically located offices in Como, Italy, and Jiangsu, China, MQMR Solutions delivers seamless support across Europe and Asia through an established and responsive international service network.

Full-cycle service

Delivering integrated, end-to-end solutions that encompass every stage of the project lifecycle, ensuring seamless execution and consistent, high-quality outcomes.

Facilitating Businesses’ Overseas Expansion

Equipping enterprises with specialized regulatory expertise to successfully navigate and expand into global markets with confidence and compliance.

End-to-End Service Offering

Lifecycle Services & Capability Building

Early Development & Clinical Programs

Process Development & Technology Transfer

GMP Readiness & Implementation

International Market Preparedness

Regulatory Registration & Commercialization

Our Growth

Unleash Your Business Potential with Our Growth

Lorem ipsum dolor sit amet consectetur adipiscing elit sed do eiusmod tempor labore et dolore magna aliqua. Donec ac lacus nec diam gravida pellentesque. Morbi viverra facilisis massa a ullamcorper eivamus egestas tincidunt faucibus tristique urna id lacinia egestas sapien arcu velit id porta.

Sterile Finished Dosage Form Facility Qualification

为无菌生产厂房提供全流程确认与验证服务，助力企业满足欧盟、美国 FDA 及世界卫生组织的 GMP

Clinical Trial Material Manufacturing for Global Submissions

按照 GMP 标准生产临床试验用药品，服务于各类跨国临床试验，全程遵循 CTD

API Manufacturing for International Markets

Technology transfer, process validation, and regulatory readiness for Active Pharmaceutical Ingredient supply to global regulators.

Biosafety Testing Laboratory Compliance

优化实验室运营体系，使其符合国际生物安全与防护标准，同步落地 OECD GLP 规范与

Sterile API and Finished Dosage Form Market Authorization

Strategic support for EU MAA, FDA NDA, and other global marketing authorization pathways.

Advanced Therapy Medicinal Products (ATMP) Support

Regulatory, quality, and compliance solutions for cell and gene therapies, tissue-engineered products, and ATMP classification.

CDMO GMP Compliance Audit for Aseptic Biologics

Independent GMP audits of Contract Development and Manufacturing Organizations specializing in sterile biologic production.

Why Choose MQMR Solutions


Operational Efficiency	Data Integrity	Risk-Based Focus
Simplifying SOPs to minimize human error, eliminate redundancies, and accelerate workflows.	Embedding ALCOA+ principles into everyday operations to ensure reliable, traceable, and audit-ready data.	Applying ICH Q9 guidelines to strategically allocate resources to the highest-risk, highest-impact areas, optimizing both compliance and performance.

Quality as a business asset

A robust QMS is not merely a compliance requirement — it is a strategic driver of cost efficiency and long-term business value.
First-Time Success: Reducing batch rejection, rework, and deviations — lowering production waste and associated costs.
Accelerated Market Access: Streamlining regulatory approvals and inspections to shorten time-to-market and capture opportunities faster.
Risk Mitigation: Supporting proactive compliance and sustained quality assurance across the product lifecycle.
By investing in quality today, you are strategically reducing operational costs and securing long-term profitability.

Testimonials

Transform Your Business with Our Proven Growth Tactics

Lorem ipsum dolor sit amet consectetur adipiscing elit sed do eiusmod tempor incididunt ut labore et dolore magna aliqua.

John Doe

Theme X

Ut enim ad minim veniam quis nostrud exercitation ullamco laboris nisi ut aliquip exea commodo consequat.

Sharon Brinson

Envato

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur dignissim enim sit amet urna cursus.

Felix Mercer

Themeforest

Sirure dolor in voluptate velit esse cillum dolore eu fugiat nulla pariatur peded lectus mollis hendrerit risus nec sem in justo.

Leona Smith

Xero Inc

Accumsan in nisl nisi scelerisque eu ultrices vitae auctor euviverra tellus in hac habitasse platea ullam non nisi est sit amet facilisis.

Piter Anderson

Loren LLC

TEAM SECTION — Experienced Experts to

Protect Your Business

Donato Longo Founder & Senior GMP Advisor Ceo

Pharmacist | API & Finished Dosage Forms | GMP Expert

With over 50 years of pharmaceutical manufacturing, GMP compliance, and quality leadership experience across Europe and international markets, Donato Longo brings unparalleled regulatory depth and hands-on expertise to every engagement. His career spans the full spectrum of pharmaceutical development and compliance — from API manufacturing to finished dosage form registration — making him one of Europe's most seasoned senior GMP authorities.

His deep understanding of both the Chinese regulatory landscape and European compliance requirements positions her as the essential bridge for Chinese pharmaceutical companies navigating their path to global markets.

Helen Wang General Manager

Mechanical Engineer | 25+ Years of China–Europe commercial operation

Helen Wang leads MQMR's China operations, bringing over 25 years of experience in pharmaceutical business development across the China–Europe corridor.

Massimiliano Stasi MD — Medical & Clinical Development Advisor

Medical Doctor | Cardiovascular Diseases | Clinical Research Specialist

Dr. Massimiliano Stasi brings over 32 years of clinical research and pharmaceutical development experience, spanning both pharmaceutical companies and Contract Research Organizations (CROs). His expertise includes management of Phase I clinical units and complex multinational studies, with a clinical background rooted in cardiovascular medicine.