There are many challenges in the transfer of manufacturing processes for advanced therapy medicinal products (ATMP’s) in comparison to the traditional and well proven biopharmaceutical route. Manufacturing processes for ATMP’s are typically designed in academic research environments and will often require additional documentation or development to ensure compliance with GMP regulations. Recognising these challenges, the Clinical Biotechnology Centre offers over 15 years’ experience to our customers in de-risking this process with a proven outcome in the successful delivery of GMP-grade products for clinical trials.
If you would like to discuss the development or transfer of a process to meet GMP compliance, please contact us.
Clinical Trial submission
In the United Kingdom, a Clinical Trial Authorisation (CTA) from the Medicine and Healthcare products Regulatory Agency (MHRA) is necessary for a clinical trial of an Investigational Medicinal Product (IMP). IMPs are substances used for clinical trials, and include placebos and controls, as well as active drugs.
They are characteristically products that are to be used to prevent or treat disease, make a diagnosis or modify a particular physiological function.
- We offer expert advice to help you identify whether your product classifies as an IMP, and to support you through Clinical Trial Authorisation process.
- We can advise on relevant legislation, liaise with relevant regulatory bodies on your behalf, support the completion of CTA documentation including Application Form, Investigators Brochure (IB) and the IMP Dossier (IMPD).
Before starting on the extensive CTA process, it is useful to identify whether your product is indeed an IMP. We can assist with this classification, and support your team in understanding applicable EU legislation.
Every CTA application will contain standard documents, including:
- Clinical trial application forms in PDF and XML
- Protocol documents
- Investigators brochure (IB)
- Investigational medicinal product dossier (IMPD)
For more detailed information on how to prepare and submit documentation for clinical trials approvals, visit the MHRA website, or contact a member of our team.