Documentation & Regulatory Support

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Documentation & Regulatory Documentation Systems

  • EU Qualified Person (QP)​ GMP audits and QP declarations.
  • Quality system design, assessment, implementation, and SOP authoring.
  • Authoring and maintenance of Site Master Files (SMF)​ and Validation Master Plans (VMP).
  • Master batch record preparation and review.
  • Comprehensive support for CTD / CEP / CMC​ documentation.
  • Preparation and compilation of regulatory submissions.

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Our Office

Italy: Via A. Manzoni 13, 22070 Carbonate (CO), Italy

China — Jiangsu: Wuxi City, Jiangsu Province
China — Zhejiang: Jinhua, Zhejiang Province

Email: helen@itamqmr.com

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