Regulatory affairs
EU language translations
Module 1.3 of the CTD marketing authorisation file must be submitted to the competent authorities in the language of the European member state concerned. Although DADA is not a translation agency itself, we partner with a top quality translation company experienced in pharmaceutical/medical translations. Of course this company translates other modules as well. DADA can therefore provide optimal support to its clients.
Services
Other services in Regulatory affairs
- Early Access programs
- Health-based exposure limits (HBEL)
- 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
- Expert reports, overviews and quality overall summaries
- Program and project management
Business hours
- Monday – Friday
- 9am – 5pm
- Saturday
- Closed
- Sunday
- Closed