Services
We collect dossiers, prepare documents, support expert reviews and certification works.
Medical Device Registration
- Classification and registration strategy
- Dossier preparation
- Filing and expert review support
Medicines
- Documents and requirements compliance
- Expert review support
- Regulator communication
Supplements
- Document package
- Labeling and composition
- Requirements consulting
Certification / ISO
- Organizing certification works
- Audit preparation
- Non-conformity support