Regulatory Affairs
ORION's Regulatory Affairs Department has a wealth of experience in gaining clinical study approvals. We have built up a first class understanding of the specific regulations for development phase studies for a wide range of products and have developed particularly strong links with competent authorities worldwide.
- Strategic regulatory planning
- Pharmaceutical, technical and regulatory consulting
- Preparation of clinical trial applications and ensuring ongoing regulatory compliance for clinical trial applications (e.g. IND, CTA)
- Preparation and conduct of face-to-face meetings with regulatory authorities
- Experience of Central and Eastern European, US, Canadian and Australasian regulatory authorities
- Gene Therapy, Viral and Environmental Committees (RAC, GTAC, CGB, GGO, VSC)
- Due diligence
- Preparation of investigator brochures