Services

We have extensive experience transferring manufacturing processes for Advanced Therapy Medicinal Products (ATMPs) to GMP for the first time, and can help you deliver GMP-grade products for your clinical trial.

Our MHRA licence permits the importation of medicinal products, such as gene therapies, biotechnology and recombinant proteins that have been manufactured and/or quality tested outside of the EU.

We aim to offer affordable regulatory advice and quality assurance support to healthcare, academic and commercial customers with our focus being Advanced Therapy Medicinal Products (ATMPs).

Our staff have the experience and know-how to develop, optimise and validate product specific assays, enabling us to offer a complete range of analytical testing services.

In the UK, a Clinical Trial Authorisation (CTA) from the Medicine and Healthcare products Regulatory Agency (MHRA) is required for a Clinical Trial of an Investigational Medicinal Product (IMP).