Regulatory Affairs Services

Embrace limitless growth possibilities with Freyr's Regulatory Affairs services. Navigate regulatory landscapes effortlessly and amplify your product's value, to dominate in the Life Sciences, Pharma, and Consumer realms. Let's elevate your product’s market impact.

For Regulatory Success, Contact Now!

Send us your details and we will get in touch.

Regulatory Affairs Services - Overview

Regulatory Affairs services play a vital role in ensuring the successful development and commercialization of drugs as they navigate the complex and ever-changing landscape of global health authorities. Ensuring compliance throughout the process is a mandatory requirement. To overlook the procedures across the product life cycle, organizations deploy proven experts for Regulatory Affairs services and consulting. The expert team acts as a crucial link between the organization and global Health Authorities, tracking all the key regulations related to the product and prerequisites for its launch. In the current situation, not many organizations have the privilege of having these teams in-house, given their dedicated focus and approach toward innovation and drug safety.

At times, as a specialized global Regulatory services Consulting partner, Freyr acts as a bridge between organizations and key Regulatory authorities like the US FDA, Health Canada, and the European Health Authorities. Freyr is a leading Regulatory Affairs services company and has been a pioneer in providing strategic Regulatory support services globally. Freyr provides comprehensive Regulatory Affairs services across the spectrum of product development, registration, and commercialization.

Freyr’s global Regulatory Affairs services consultants enable Life Sciences, Consumer, Pharma and Biological products and Medical devices companies to understand and efficiently manage the demanding complexity of the diverse Regulatory requirements to successfully launch their products in new markets and maximize their market value.

Regulatory Affairs Services - Expertise

  • 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

Partnering with Leading Organizations

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​