Regulatory advice and QA support
We aim to offer affordable regulatory advice and quality assurance support to internal, NHS, academic and commercial customers with our core focus being European (EU/EEA) Regulatory Affairs for Advanced Therapy Medicinal Products (ATMPs).
ATMPs are a complex and wide-ranging group including gene and somatic cell therapies and tissue engineered products. Whilst these are governed by standard EU regulatory requirements for medicines, there are also several specific guidelines relevant only to ATMPs.
We offer a range of expert services including advice on:
- Preclinical and early program development
- Product and process development, including QA support
- EMA classification and certification procedures
- EMA/CHMP procedures and guidelines
- Regulatory strategy and compliance
- Clinical trial applications
- Agency interactions (UK and EU)
- Scientific due diligence
- QP Services
For additional services, please contact one of our expert team to discuss your requirements