PRE-SUBMISSION ACTIVITIES
- Regulatory Strategy Design for dossier approval
- Dossier Gap-Analysis
- Development Support
- Full Dossier Preparation for Submission
- eCTD dossier publishing
DOSSIER SUBMISSION
Procedures to obtain Product Marketing Authorisation
- Centralised Procedure (CP)
- Decentralised Procedure (DCP)
- Mutual Recognition Procedure (MRP)
- Repeat Use Procedures (RUP)
- Duplicate Procedures
- Line Extensions
- National Procedures
- Europe
- MENA Region
- CIS countries
- GCC countries
- Balkans
With our deep know-how and established network, we can manage on our customer’s behalf, the registration procedure and successful Marketing Authorisation in many territories worldwide.
Registration Procedure Management
- Submission of dossier through CESP or local Authorities platforms
- Deficiency letters responses
- National phase documentation preparation
Authorities Liaison
Our international outreach gives us the possibility to communicate and liaise with local Health Authorities to facilitate the course of the registration process.