Pharmaceutical Safety & Efficacy
Early Access programs
Early Access Programs (EAPs), also known as Compassionate Use Programs (CUPs), can help ensure patients access to investigational medicinal products outside of clinical trials or after the trials have been completed, until the marketing authorisation of the drug has been granted and the product becomes commercially available. DADA has experience in planning and applying for Early Access Program authorisations in Belgium, the Netherlands, and Luxembourg. Together with our European partners we can assist you with setting up your Early Access Program, submit your application and take care of the communication with the drug regulatory authorities in all EU member states.
Services
Other services in Pharmaceutical Safety & Efficacy
- Clinical Trial Authorization Applications
- Phase 1 Environmental Risk Assessment (ERA)
- Quantitative Structure-Activity Relationship (QSAR) assessment according to ICH M7
- Health-based exposure limits (HBEL)
- Clinical and non-clinical sections of the registration dossier
- CRO selection and auditing
- Clinical study related documents
- Advice on study designs (PK, PD, clinical and PASS)
- Medical review
- Scientific advice
- Feasibility studies
- Biostudies and biowaivers
Business hours
- Monday – Friday
- 9am – 5pm
- Saturday
- Closed
- Sunday
- Closed