Regulatory affairs
Expert reports, overviews and quality overall summaries
At the moment DADA has produced more than 1300 state-of-the-art expert reports, (non)clinical overviews and quality overall summaries that have been successfully included in marketing authorisation applications approved throughout Europe. DADA guarantees compliance of its expert reports, (non)clinical overviews and quality overall summaries with all current regulatory requirements.
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 applications
- Marketing authorisation dossiers and maintenance
- Local representative of the Marketing Authorisation Holder
- Program and project management
Business hours
- Monday – Friday
- 9am – 5pm
- Saturday
- Closed
- Sunday
- Closed