Methodological aspects of the development of product files for biomedical cell products

Preparation of a product file (PF) for a biomedical cell product (BCP) is an important stage in the preparation of documents for marketing authorisation. The PF is the main document of a regulatory submission and is used as the basis for BCP quality control. The requirements for the content of a PF,...

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Bibliographic Details
Main Authors: E. V. Melnikova, O. A. Rachinskaya, O. V. Merkulova, I. S. Semenova, E. O. Kozhevnikova, V. A. Merkulov
Format: Article
Published: Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» 2021-07-01
Series:Биопрепараты: Профилактика, диагностика, лечение
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