Overview

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.

 

Freyr Capabilities

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 )
  • Re–registrations
  • 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
 

Freyr Advantages

  • 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 Markets

Freyr helps a global client ensure $100s of Million in Sales continuity for Top 20 brands through on-time CMC services.
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CLIENT TESTIMONIALS

 
  • Under the EMA’s tight timelines, your resource has successfully delivered on commitments with overwhelming speed and decisiveness ensuring we met the requirements on time. We just wanted to recognize their hard work and diligence on the product information update for a drug. Within just few weeks of their stint at our organization, they successfully navigated our processes and integrated them into the product team. Quite impressive! We must reiterate!

    Senior Regulatory Associate, Worldwide Regulatory Strategy
    A leading research-based global Biopharmaceutical Company

  • On behalf of the entire team, I’d like to thank you for your hospitality. We understand that hosting us took time away from your day-to-day activities, and we just wanted to say thank you for everything you did to make this a very interactive, productive and successful visit for us. We would especially like to pass along our appreciation to the entire Freyr team for partnering in our mission to serve patients.

    - Director, Supplier Performance Management, Global Regulatory Affairs & Safety
    Forbes Global Top 10 Biopharma Company

  • Thanks so much for all the help and diligence. We are so impressed by the way things have been handled by Fryer and the level of competence.

    We have another very similar project coming up in the next few weeks where we need exactly the same level and type of service which we will be delighted to talk to you further.

    – Program Manager, Regulatory Affairs – Global $1Bn Pharma Company

  • Thanks for the great work you are doing, sharing the great principles that Freyr uses for its employees and your focus on sustainability.

    – Head of Procurement, Fortune 100, Global Top 10 Consumer Healthcare & Pharma Company