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.
Upcoming Webinar
Overview of the NDA/BLA Process in South Korea
November 29, 2023
For AMR & EUA
10: 00 AM EST | 3:00 PM GMT | 4:00 PM CET
For ROW
11:30 AM IST
Our global pharma Regulatory affairs consulting services include the following:
- 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
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.
Experience Comprehensive Regulatory Affairs Consulting Support
Partner with UsTake a sneak peek into Freyr, who we are and what we can do for you?
Drugs, Biologics,
Cosmetics and
Medical DevicesOur professionals specialize in all facets of pharmaceutical and medical device development and regulation
-
FDA, Health Canada
and EU ExpertiseTake a sneak peek into Freyr, who we are and what we can do for you
Full Lifecycle
SupportEnd-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
USA
UK
GERMANY
INDIA