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Quality Management and Certification by Qualified Person

Effective Quality Management capabilities are essential for successful CDMO services. All functions and operations must at all times be carried out in compliance with GMP and other regulatory requirements. Biovian has an experienced Quality Management team that reviews every aspect of the manufacturing, from raw materials to final shipping, and makes sure that Good Manufacturing Practice is followed. We also have our own team of Qualified Persons (QPs). Your investigational medicinal products (IMPs) for use in clinical trials are certified by a Qualified Person before shipping. An excellent quality record is our key driver.

Our QM and QP services include the following:

GMP advise during biopharmaceutical product development and production
Regulatory support for biological Drug Substances and Drug Products.
Full GMP documentation, including GMP certificates. Detailed batch records
QA approval of GMP Cell Banks and Viral Seed Stocks. QP certification of the batch (Drug Substances, Drug Products, IMPs)

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