Regulatory affairs
Marketing authorisation applications
As mentioned, various marketing authorisation procedures can be used in Europe. The actual submission of the dossiers to regulatory authorities, subsequent monitoring of the procedure, responding to regulatory queries and the formal ending of the application procedure is a complicated and time consuming activity. DADA has gained extensive experience in these activities and is able to manage complete CP/DCP/MRP projects involving all European countries on your behalf.
Services
Other services in Regulatory affairs
- Early Access programs
- Health-based exposure limits (HBEL)
- EU language translations
- PIL user testing
- Certificate of a Pharmaceutical Product / Free sales certificates
- Reimbursement applications
- Appeals and hearings
- Due diligence and in- and out-licensing support
- Organisational advice
- Scientific advice
- Feasibility studies
- Regulatory strategy
- Marketing authorisation dossiers and maintenance
- Local representative of the Marketing Authorisation Holder
- Expert reports, overviews and quality overall summaries
- Program and project management
Business hours
- Monday – Friday
- 9am – 5pm
- Saturday
- Closed
- Sunday
- Closed