Fully cGMP Compliant Services
Fully characterizing your biosimilar is a regulatory requirement. Another is biosafety testing, as required by the FDA (Food and Drug Association) and the EMA (European Medicines Agency) to ensure your product is free of contaminants.
We pride ourselves in being a leading provider of cGMP biosafety testing for biopharmaceutical drugs and vaccines. Offering a comprehensive range of off-the-shelf biosafety assays, including, but not limited to, sterility testing, in vivo and in vitro assays, and genetic stability testing.