Regulatory affairs
Program and project management
DADA can offer complete program and project management solutions using its extensive knowledge and experience in product development and the registration of generic and generic 'plus' human and veterinary medicinal products. This includes large projects as described under product development as well as sub-projects, such as the management of complete centralised procedures (CPs), decentralised procedures (DCPs), mutual recognition procedures (MRPs), translational work, management of CRO selection, preparation of documents for variation applications etc.
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
- Expert reports, overviews and quality overall summaries
Business hours
- Monday – Friday
- 9am – 5pm
- Saturday
- Closed
- Sunday
- Closed