BioOutsource — cGMP compliant biotesting
Regulatory and Technical Support
BioOutsource Scientists and Quality Systems Managers can offer expert advice on the regulatory and testing requirements for batch release testing of Vaccine and Biologic products and will always support our clients in negotiations with regulatory submission.
Our scientists also have an in depth knowledge of the current guidelines, but perhaps more importantly we have excellent communication with some of the key regulators who can assist in future proofing your testing regimens with respect to technical and regulatory requirements. This resource will ensure the timely, cost effective and successful licensing of the therapeutic product.
BioOutsource can provide support for dossier preparation and submissions to the regulatory authorities. Specific reports are prepared for each development study in support of batch release but these can be adapted depending on our client’s format requirements.
Our technical team are always available to assist in the development of molecular and cell based assays to support BioPotency assays for batch release and stability testing.
