Regulatory Affairs Services – An Overview

Freyr provides comprehensive Regulatory affairs consulting services across the spectrum of global product development, registration, and commercialization. We offer informed advice and pragmatic solutions for new product registration and market authorization, Health Authority (HA) submissions, post-approval changes, CMC, and lifecycle management. Our Regulatory affairs consultants help companies maximize their product’s commercial potential and market success.

Regulatory Affairs Services – Freyr Expertise

Freyr’s global Regulatory compliance consulting services enable life sciences, consumer pharma, and bio-med companies to understand and efficiently manage the demanding complexity of diverse Regulatory requirements and successfully launch their products in new markets and maximize the value of their assets.

Our global pharma Regulatory affairs consulting services include the following:

  • Submission Forecast
    and Planning
  • Submission Document
    Management and Tracking
  • Regulatory Content
  • Change
    Control Management
  • Label Change Tracking
  • Integrated
    Regulatory Information
  • Regulatory Intelligence
  • Reporting and Analytics



European Union

Our Role as a Specialist in Regulatory Affairs Services

Freyr acts as a bridge between global drug developers and key regulators like the US FDA, Health Canada, and the European HAs. We have a global customer base ranging from small biotech startups to multinational corporations. We partner with customers to help them create a successful Regulatory strategy by using a scientific approach and years of Regulatory affairs consulting experience as the drive.

Freyr’s highly skilled team of Regulatory affairs consultants has complete knowledge of global HAs’ Regulatory frameworks and can partner with you to accomplish your Regulatory and business objectives. As an end-to-end Regulatory affairs services provider, Freyr offers pharma Regulatory affairs consulting to global companies.

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By Services

By Region

  • North America
  • Europe

Regulatory Affairs Consulting