Regulatory affairs
Due diligence and in- and out-licensing support
Whenever a pharmaceutical company signs an in-licensing contract, the quality of the existing data in the form of files or dossiers should be duly evaluated. DADA is not only well able to evaluate this regulatory dossier, but we can also support you in assessing the proposed contracts concerning this transaction. And via our network we can bring an interesting project to the attention of potential in-licensors.
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
- 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