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.

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

What Our Clients Say?

It is good for submission. And I understand today is a holiday, so I have to thank Freyr team for doing this. FDA called us and is trying to close out the CBE-30 filed in March and wanted these documents as soon as possible. So, I truly appreciate your assistance, even on a day off.

President

An Innovative Pharmaceutical Company

This project, eCTD DMF conversion, was against a very tight schedule and required dedicated resources. Freyr provided the dedicated resources needed to meet our immediate Regulatory filing requirements. Freyr was always on schedule/or exceeded the dates outlined in the project plan. All changes were handled within 24 hours and notifications of changes were promptly provided. This project is not yet complete but has been very successful at this point.

Quality Control and Regulatory Manager

USA-based Pharmaceutical company

The ANDA receipt is 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 look forward to working with your team on the next project!

Research and Technology based US pharmaceutical company

Excellent! Congratulations to the team for this accomplishment! Thank you everyone for your hard work on this. In addition, please let us know what is needed for the submission of the Type III DMF to Health Canada. I assume we will need to update some of the initial administrative documents, but most of the content is identical to the Type IV DMF.

Senior Research Assistant,

US based leading biopharmaceutical company

We have crossed two important milestones in two days, thanks in a large measure to all of you. We are a small company, a small set of people with big dreams. And given the industry we are in and how we operate, it is possible to realize our dreams only with the help of partners like you - who share our beliefs and push hard with their own collective might. On behalf of our organization, I would like to thank you for your competence and commitment in delivering ANDA files. Kudos to the whole team.

Operations Head,

A Privately Held Pharmaceutical Research and Development Company

Thank You Freyr team for a Fantastic 2019! The OTCDOCS TD user community feels better supported despite the technical challenges and system constraints. Thank You for being the voice to represent their ways of working and helping us design a more user friendly, effective system going forward.

System Owner,

UK multinational pharmaceutical company

Great job with your impact and for noticing that there was an error on the insert SAP code. This shows great attention to detail as well as expertise in all the other point areas that you are thoroughly investigating, regarding the QA database etc.

Graphics Manager | Global Regulatory Affairs,

Canada based, global pharmaceutical company