About Us
Consultancy in Regulatory Affairs to the Pharmaceutical and Medical Device Industries specialising in Medical Technology and the Borderline with Pharmaceuticals and also Vaccinology
Business areas
- Clinical investigation notifications for Pan-European clinical investigations of Medical Devices
- Advice on the impact of Regulation, Directives and Guidelines especially on Medical Devices
- Assistance with arranging meetings with regulatory agencies and follow up liaison
- Training in the areas of the Drug Device Borderline
- Wide experience of different types of Medical Device including Advanced Therapy products
- Due diligence assessments for Medical Technology Products