Approved products constantly undergo changes pertaining to Chemical composition, Manufacturing process, transfer of manufacturing sites, Labels etc. and many of these changes have to be reported to Health Authorities, based on the Regulations prevailing in the respective Markets. Freyr’s Regulatory CMC, Center of Excellence (CoE), can offer significant Cost – Benefits in reducing Regulatory costs associated with Variations / Amendments Submission & Dossier Preparation activities. Freyr Regulatory CMC CoE is one of the pioneers in offering Offshore-based CMC & Change Control support services. CMC functions typically are tightly integrated & complex processes with several hand-offs and coordination with multiple stake-holders in R&D, Regulatory, Supply Chain & Commercial Operations. Freyr has successfully established Offshore-based CMC Operating & Delivery Models, by tight-integration with our customer’s global CMC processes.
Global CMC Services
- End-to-End Product or Franchise responsibility for Global CMC activities associated with the products or product categories
- Regulatory Dossier Preparation for Variations (Complex, Type IA, IN, Type IB, Type II and Type II Complex) / Amendments / Annual Updates to ANDA, MAA, DMF etc.
- CMC Gap Analysis
- Response to Health Authority questions & Health Authority interactions
- Manufacturing Site Transfers, Additions, shut-down
- Preparation, Revision, Review of Module 3 & Module 2.3 and other modules, as applicable
Registrations and License Management Services
- Registrations & License Renewals for global regions (including regions like Eastern Europe, Russia, Asia Pacific, Africa )
- EU – Specific Services related to MRP, DCP, National Licenses (eg: Extension of National License to MRP License )
- Global Registrations / License tracking & management
CMC Change Control Coordination Services
- Evaluation of Change Controls for EU & Other regions
- Product Quality Reviews & Annual Product Reviews
- Ongoing monitoring of Changes made to Products, throughout the year
- Evaluation of documentation as per the recurrent changes in drug constituent and drug manufacturing sites
- Annual reports and renewals to ensure sustained market access for a company’s product line
- Progressive functioning models to provide certainly and at scale by influencing external assets
- All over the world service delivery competence for advantageous cost alignments
- Provide support around-the- clock
- The concept of “first-time-right” outputs to ensure timely approvals
Sales of $100s of Millions Successfully Ensured For Top 20 Global Brands in EMEA & CIS MarketsFreyr helps a global client ensure $100s of Million in Sales continuity for Top 20 brands through on-time CMC services.