Batch Release Testing
Conformance testing for release to the European Market
Within the European Union (EU), there is a regulatory requirement that each batch of a finished marketed product be tested in the EU against the approved product specification. You need a partner that can provide you with a turnaround that shortens the time from product manufacture to availability to the patient.
With quality controlled laboratories on site that provide both chemical and microbiological support we offer:
- A wide range of analytical resources
- Complete compendial analysis (BP, EP, JP and USP)
- Experience and expertise in Batch Release testing of products manufactured outside the EU
- IMP batch release testing and re-test
- Method transfer and analyst exchange
- FDA and MHRA audited laboratories
As an approved and accredited laboratory with a long history of batch release testing to the Medicines Testing Scheme, we provide a wealth of experience across a wide range of product types.
For further information on our Global service offering please email firstname.lastname@example.org