Regulatory Offerings

Freyr provides comprehensive Regulatory services across the spectrum of global product development, registration and commercialization. We deliver informed advice and pragmatic services and solutions for new product and market authorizations, Health Authority submissions, post approvals, CMC and lifecycle management to help companies maximize their product’s commercial potential and market success.

Freyr's Comprehensive, End-to-end Regulatory Affairs Services

Freyr’s global Regulatory affairs expertise enables Life Sciences, Consumer Pharma and Bio-Med companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements, in order to successfully launch their products in new markets and maximize the value of their assets.

Global Regulatory Affairs Consulting Capabilities

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

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European Union

What We Do?

Freyr, acts as a bridge between global drug developers and key regulators like, the US FDA, Health Canada, and the European Health Authorities. We have a global clientele ranging from small biotech start-ups to multinational corporations. We partner with clients to help them achieve constructive Regulatory Strategy and outcomes, using a scientific approach as the driver of success drive.

Freyr’s highly skilled team commands a breadth and depth of knowledge pertaining to the US FDA, Health Canada, and the European HA’s Regulatory frameworks and can partner with you to accomplish your Regulatory and business objectives. Freyr develops Regulatory strategy for your product, by providing a clear path forward through all the important milestones to attain a successful outcome.

How To Get Started?

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By Services

By Region

  • North America
  • Europe

Regulatory Affairs Consulting