Overview

One of the key capabilities of Freyr is to offer high-value Regulatory Affairs consulting & Dossier services for several Regulatory functions, including New Product Introductions / Roll-outs, to various global markets, including North America, EU, Middle East, Africa, Asia & CIS regions. Many of our core Regulatory Affairs services are offered in Onsite / Offshore model. Key functions that have to be done locally are supported by Freyr’s Global Regulatory Affiliate Network (A network of highly skilled regional Regulatory Affairs experts in the Respective geographies) and functions that can be done from offshore (for eg. Dossier compilation, QC and Submission) can be handled out of Freyr’s Global Regulatory Operations Center (GROC) in Hyderabad, India.

 

Freyr Capabilities

  • New Product Launch:
  • Regulatory Process Optimization
  • Regulatory Strategy Consulting
  • R&D Support (Data Generation for Regulatory Filing)
  • Gap Analysis of Regulatory Documents
  • Change Controls Management
  • Post Approval Changes Management
  • Cost-effective, Onsite / Offshore models
  • Submissions into ICH or a respective country’s accepted format (CTD/ NeeS/ eCTD) for both conventional (e.g. solid orals and liquid orals) and non-conventional (e.g. Parenteral and Transdermal Therapeutic Systems) dosage forms
  • Effectively handling the ‘Change Controls’ co-ordination and assessment of the assigned changes, wherein the regulatory impact of the changes made to the product or its components are first collected from the impacted markets and then assessed in the change control system
  • Accomplishing the product compliance status by monitoring the submission and approval status of the assigned products in the relevant system
 

Freyr Advantages

  • Extremely Cost-effective  and Flexible Engagement Models (Cost Savings of 60% or upwards)
  • Onsite / Global and Offshore-based Regulatory Affairs teams with diverse therapeutic and health authority experience
  • Proactive and Collaborative Approach
  • Highly Qualified Professionals
  • Rich Healthcare and Life Sciences domain experience
  • Worldwide Services and Delivery Capabilities
  • Quick turnarounds and Faster time-to-market
  • Quality deliverables before/on time
 

Multiple HA / Agency Renewal Drafts For 15 Products In Short Timelines

Freyr performed a CMC ‘Gap analysis’ for all 15 products along with documentation collected from the different sources of client with the recommendations on R&D work.
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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