Regulatory Affairs
Regulatory affairs departments interact with worldwide, federal, state, and local regulatory agencies to assure that the following activities involving pharmaceutical and medical products are conducted in compliance with all applicable rules: Licensing. Registration. Development.
Services
EU marketing authorization applications
- Article 10 (1)
- 10 (a)
- 10 (C)
- 10 (3)
MIA
- WDA applications and variation support
All Type IA, Type IB, and Type II MA Variations (i.e. Quality, safety & PIQ, etc.)
Renewal application & submission Change of ownership application
Submission Reclassification variations (POM, P & GSL)
Due diligence for license transfer/acquisitions
Sunset clause application
Preparation of PLPI application and submission
Innovator/ Reference product procurement
Regulatory Documents Preparation
- SMPC
- Label
- PIL
- RMP