stage1 :REGULATORY OFFERING
Targeted support that reflects the guidelines in force (including MEDDEV 2.1/3)
Production of all or some of the documents required:
- Proof of the usefulness, quality & safety of the combined MD
- Benefit/risk profile of the medicinal substance incorporated and considered to be an accessory
- Risk management
- Preclinical and clinical evaluation
Assistance in compiling the Regulatory Technical File and the key elements associated with your Combined MD.
Support in your dealings with your notified body and the ANSM.