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
- Submission Document
Management and Tracking
- Regulatory Content
- Label Change Tracking
- Regulatory Intelligence
- Reporting and Analytics
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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Take a sneak peek into Freyr, who we are and what we can do for you?
Our professionals specialize in all facets of pharmaceutical and medical device development and regulation
FDA, Health Canada
and EU Expertise
Take a sneak peek into Freyr, who we are and what we can do for you
End-to-end services, right from the early stage development, through the approval and commercialization of your product, our highly skilled professionals can help with all your regulatory needs across the entire product lifecycle