The Quality Management System covers three tiers of quality; research with GRP WHO guidelines as basis; process development based on GRP and ICH Q8/9/10, assay development and validation based on ICH Q2; and GMP based on EU GMP and ICH Q10.
Batavia Biosciences is licensed by the Dutch authorities for the release of biopharmaceuticals (license number 5468 F) according to EU GMP regulations. The license covers the release of biopharmaceuticals in the category immunological products, gene therapy products and biotechnology products. Next to the release, the license covers QC testing.
The Quality Assurance team at Batavia Biosciences has ample track record in supporting successful IND and IMPD programs. The team works closely with its sponsors to ensure that the appropriate documentation is delivered in a timely manner according to the requirements defined in a Quality Agreement. The Batavia Biosciences QA and QC department is intimately involved in the release of your product. Batavia Biosciences has successfully supported a number of IND’s and IMPD’s covering diverse biopharmaceuticals both novel as well as biosimilar products.