NPD (New Product Development):
- Focus on DCP/MRP/national applications: Generics, Extensions, Well-established–use, Bibliographic or Hybrid application support to meet your timelines.
- Preparation and execution of electronic submissions to European regulatory authorities (via CESP) of Human medicines.
- Specialization in Herbal Medicinal Products for human use: Traditional use/Well-established use applications
- Preparation of Module 1, Module 2.3 and Module 3