We offer expert manufacturing and regulatory support in translating processes into regulatory dossiers.
Our Quality Management System covers three tiers of quality: Research with GRP WHO guidelines as a basis, Process Development based on GRP and ICH Q8/9/10 and for Assay Development to ICH Q2 and finally, GMP based on EU GMP and ICH Q10.
Batavia Biosciences is licensed by the Dutch authorities for the production of biopharmaceuticals (license number 5468 F) according to EU GMP regulations. This license covers the release of biopharmaceuticals in three categories: biotechnology products, gene therapy products and immunological products. Batavia Biosciences’ QA and QC departments are closely involved in the release of products.
The operators of production and QC are responsible for accurately and faithfully recording all data generated during the manufacturing and testing of components and products. The head of production and QC review the data generated, while QA audits the documentation and compiles the batch dossier. Our in-house QP reviews all batch-related documents, approves the Certificate of Analysis and the Certificate of Compliance and registers the release of the batch in the Batch Manufacturing Log. The customer may audit the batch dossier on site at Batavia Biosciences or by review of copies submitted to the customer.
We have successfully supported many INDs and IMPDs covering diverse biopharmaceuticals and both novel and bio-similar products. Our experienced staff offers their support in the preparation and review of the CMC section of the IND or IMPD and in meetings with the regulatory authorities. Even though we support IND/IMPD documentation, we do not file the IND/IMPD nor perform pre-clinical safety studies and clinical studies.