Services
Pharmaceutical Safety and Efficacy (PSE)
- Clinical Trial Authorization Applications
- Phase 1 Environmental Risk Assessment (ERA)
- Quantitative Structure-Activity Relationship (QSAR) assessment according to ICH M7
- Early Access programs
- 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