Regulatory affairs
PIL user testing
In accordance with current legislation, Patient Information Leaflet readability testing is a mandatory part of a human medicinal product marketing authorisation. DADA is partner with a top quality readability testing company.
Services
Other services in Regulatory affairs
- Early Access programs
- Health-based exposure limits (HBEL)
- EU language translations
- 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