Lot and Final Drug Product Release
Batch release testing in accordance with specifications
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 control laboratories on site that provide molecular biology, chemical and microbiological support we offer:
- A wide range of analytical resources including:
- Western Blot
- Residual DNA
- BCA testing
- SDS-PAGE Analysis
- SEC-HPLC (Aggregation)
- Sterility and endotoxin
- Colorimetric Assays
- Complete compendial analysis (BP, EP, JP and USP)
- Experience and expertise in Batch Release testing of products manufactured outside the EU.
- IMP batch release 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, we provide a wealth of experience across a wide range of product types.
For further information on our Global service offering please email email@example.com