Source Bioscience is a leading independent, MHRA approved (cGMP) contract research organisation that specialises in the provision of chemistry, manufacturing and control (CMC) laboratory services for all phases of drug development. We support the pharmaceutical research and development process from preclinical enabling studies for investigational medical products (IMPs), through the clinical research phases to batch release testing into the market place.
As part of our provision of the service we conform to current Good Manufacturing Practices (cGMP). Source Bioscience offer the following general testing routinely to the Pharmaceutical Industry.
Pharmaceutical Chemistry Testing:
- Stability storage & testing to ICH guidelines with 92 environmental chambers.
- Method development and validation (ICH)
- Method transfer
- Clinical trial support (method development, batch release and stability)
- Pharmacopoeia testing (BP, USP, Ph.Eur, JP on raw materials, excipients, intermediates & finished products)
- Batch Release Testing to Pharmacopoeia or Customers Methods
- Consultancy services and supply of trained Full Time Equivalents.
- Supply of Experienced Full-Time Equivalents Pharmaceutical
- QP release testing providing certification that batch release is in accordance with the relevant regulations for licensed pharmaceuticals
Our pharmaceutical chemistry department is one of the finest equipped and most professional contract testing facility in Europe. We have a specialism for inhaler testing with 8 Andersons and 25 HPLCs. Quality comes first and foremost for the high technology delivery system. Whether it is developing and validating methods for novel pharmaceuticals or delivering routine Pharmacopoeia testing on API’s, raw materials, excipients and formulations. With fast on time delivery of projects we work in partnership with our customers to ensure they meet their business objectives. The above list is not exhaustive and additional testing is available on request.
For further information and prices please contact us or call +44 (0)115 973 9012