Regulatory Support

Our Regulatory Support team ensures that all GMP manufacturing and analytical operations comply with regulatory requirements. Our missions includes the preparation of appropriate documentation in collaboration with R&D, manufacturing or analytical teams, the review and compilation of batch records, the release of clinical material by our Qualified Person as well as the audit and selection of suppliers.

We also provide assistance to our clients in the understanding of the regulatory environment associated to their complex biological products.

Quality Assurance

Our GMP manufacturing facilities are regularly inspected by the French Authorities and a copy of our GMP certificate can be made available upon request. We are compliant with EMEA and FDA guidelines and have already released Drug Products to be used in clinical trials in Europe and in North America.