Regulatory Medical Writing Competencies

 

Regulatory Medical Writing Competencies - Overview

Freyr is a preferred global Regulatory writing services provider for writing, performing an independent quality review, conducting thorough technical review of dossiers and identifying gaps/performing gap analysis in already prepared/compiled dossier. Our Regulatory medical writing professionals can cater to the needs of various regional Health Authorities (HAs) of North America, EU, Middle East and North Atlantic region, and other APAC nations including India, China and Philippines.

Regulatory Medical Writing Competencies - Expertise

Clinical And Nonclinical Overviews
  • Clinical and nonclinical overviews for HA submission
  • Ready to submit Module 4 and Module 5 documents
  • Ensure proper usage of applicable templates for Clinical and Nonclinical overviews
  • Module 1.4.2 and Module 1.4.3
IND And Pre IND-Services
  • Designing of nonclinical development program
  • Pre IND-Briefing Package
  • General Investigation Plan (GIP)
  • Pre IND-meeting support
  • Support and strategic planning
Quality Control/ Clinical And Nonclinical Expert Review
  • Quality control of MW documents
  • Medical expert review for CO
  • Nonclinical expert review for NCO
  • Signature pages (M 1.4.2 and M 1.4.3) along with Expert CV
  • QC to assure data accuracy, consistency, correct interpretation, formatting and style guide requirements based on the client’s preference
Toxicological Risk Assessments
  • Health-based exposure limits (PDE & OEL)
  • Toxicological evaluation of new excipients
  • Cosmetic Safety Assessment Report (CPSR)
  • Toxicological risk assessment of flavors and additives
  • Toxicological assessment of impurities and degradation and related substances
Clinical And Nonclinical Summaries
  • Clinical summaries for NCEs and generics
  • Nonclinical summaries for NCEs and NBEs/biosimilars including 502(b2)
  • Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
Clinical Protocols
  • Protocols and amendments for all phases of the clinical trial
  • Proof of concept and confirmatory studies across diverse therapeutic areas
  • BA/BE studies
  • Protocols for first in human studies including SAD, MAD, ADME, HAL studies, safety and efficacy studies
Clinical Study Reports
  • Shell preparation, TLS and complete CSR preparation
  • Phase I - Phase II clinical studies
  • BA/BE studies
Investigator’s Brochure
  • IBs for Phase I and II studies
  • Updating IBs based on the clinical studies
Regulatory Medical Writing Competencies

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​