Regulatory affairs
Appeals and hearings
DADA also supports its clients in appeals and hearings. Due to extensive pharmaceutical knowledge and knowledge of EU regulatory affairs, DADA has been able to support its clients in court cases, appeals and hearings throughout Europe.
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
- 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