Regulatory affairs
Reimbursement applications
After granting the marketing authorization, the product concerned must be included in the national reimbursement system of each member state concerned. In the Netherlands this means that a reimbursement file must be submitted to the authorities. DADA can support you in compiling these reimbursement files.
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
- Appeals and hearings
- Due diligence and in- and out-licensing support
- Organisational advice
- Scientific advice
- Feasibility studies
- Regulatory strategy
- Marketing authorisation applications
- 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