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,...
|Main Authors:||, , , , ,|
Ministry of Health of the Russian Federation. Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products»
|Series:||Биопрепараты: Профилактика, диагностика, лечение|