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

Latest Resources

  • Blogs

    ANVISA Becomes a Member of PIC/s Committee

    ANVISA Becomes a Member of PIC/s Committee

    Read More
  • White Papers

    Factors that May Cause FDA to Refuse to Receive (RTR) an ANDA

    Factors that May Cause FDA to Refuse to Receive (RTR) an ANDA

    Read More
  • Webinars

    Strategic Regulatory Partnerships How to Evaluate & Engage with a Regulatory Partner

    Strategic Regulatory Partnerships How to Evaluate & Engage with a Regulatory Partner?

    Read More

What Our Clients Say?

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