Regulatory Strategy and Insights

Staying updated with dynamic pharma and biotech regulations becomes effortless with our strategies ensuring compliance and successful product approvals. By providing Regulatory consulting to AI solutions, we guide you smoothly through every step of the M&A. With Freyr, your success is assured.

Regulatory Strategy and Insights - Overview

In the highly regulated pharmaceutical and biotechnology industries, a well-defined Regulatory strategy is essential for successful product entry and managing the complexities in global markets. Our comprehensive suite of services provides insights and solutions to meet global Regulatory requirements, enhance compliance, and support successful product approvals. We offer strategic Regulatory services to assist pharma, biotech, and life sciences firms in developing and executing effective Regulatory strategies.

Regulatory requirements vary significantly across regions and staying updated about the latest Regulatory changes and new mandates is critical for maintaining compliance and achieving timely approvals. Our strategy and insights enable you to confidently navigate the complex Regulatory landscape, ensuring successful product development and approval.

Our service offerings include:

  • Regulatory Strategy Consulting
  • Regulatory Submission Roadmaps/Regulatory Intelligence Services
  • Gap Analysis/Due Diligence
  • AI-Powered Regulatory Services
  • Customizable Regulatory Newsletters and Reports

Regulatory Strategy and Insights

  • Development of comprehensive business goal-oriented Regulatory strategies
  • Expertise in navigating complex Regulatory trends globally
  • Creation of detailed submission roadmaps for efficient Regulatory filings
  • Identification of Regulatory gaps and implementation of mitigation strategies
  • Exploration of eligibility methods to obtain possible benefits from Regulatory agencies to foster the application review process and receive certain perks
  • Experts with in-depth and up-to-date knowledge of global Regulatory landscapes
  • Data and expertise-driven insights for informed decision-making
  • Extensive network of Regulatory experts across multiple regions and different product portfolios
  • Ability to manage and handle Regulatory projects in diverse markets per health authority (HA) expectations and requirements
  • Complete Regulatory endorsement of the project, right from filing strategy preparation to HA interactions and query responses to market approval
  • Comprehensive support throughout the product lifecycle

Celebrating Customers Success

 

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

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

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​