Regulatory Medical Writing Services - Overview

Regulatory medical writing is an indispensable aspect of any Regulatory submission for Pharmaceuticals. Developing accurate clinical and nonclinical documents for Regulatory submission dossiers under medical writing requires an in-depth understanding, experience, and thorough knowledge of the Regulatory guidelines. 

Freyr is a significant achiever in Regulatory medical writing and has vast experience and expertise coupled with a team of highly qualified medical and scientific writing professionals. At Freyr, well-established processes governed by SOPs, checklists, and reviews ensure that the quality of documents is maintained at the highest standard. Our Regulatory medical writing team is also flexible in adapting to client-specific processes and templates for the development of any documents. The alignment of Regulatory writing experts and other team members based on project-specific requirements ensures better time management through an efficient transition to project completion. 

Our experts have developed numerous documents for a variety of submissions across the globe. Our medical writing team is well-versed in dealing with submissions for the US FDA, EMEA, MHRA, and other regulated and semi-regulated countries.

The full range of medical writing services at Freyr includes the following:

 

Regulatory Medical Writing Services - Freyr Expertise

  • Strategic Regulatory writing support for clinical and nonclinical development according to the submission type and Regulatory authority.
  • Preparation and review of nonclinical & clinical overviews and summaries (eCTD Module 2.4, 2.5, 2.6, and 2.7), including the preparation and review of eCTD Modules 4 and 5.
  • Preparation and review of Clinical Study Report (CSR, eCTD Module 5).
  • Preparation and review of Clinical Trial Protocol (CTP), Investigator Brochure (IB), efficacy and safety summaries, and patient/safety narrative writing.
  • Support on Integrated Summaries (ISS, ISE, and ISI).
  • Clinical justification documents for the EU, US, and other emerging Regulatory markets.
  • Biowaiver support for product approval and strategic support for study design.
  • Justification for abuse liability assessment.
  • Expertise in clinical (GCP) and bioanalytical (GLP) facility audits and support in study-specific monitoring.
  • Toxicological Risk Assessment (TRA) of impurities, extractables & leachables, excipients, and industrial chemicals.
  • Permitted Daily Exposure (PDE) and Occupational Exposure Level (OEL) calculations.
  • Scientific writing services like publications, abstracts, posters, brochures, PowerPoint presentations, literature searches, and reviews.
  • Ad Promo services like the Regulatory and medical reviews of advertising and promotional materials.
  • A holistic review of promotional products with compliance management.
 

Regulatory Medical Writing Services - Freyr Advantages

  • A team of over forty (40) medical writing experts, which includes clinical, nonclinical, and scientific writers.
  • In-depth Regulatory medical writing knowledge like the ICH-GCP, EMA, and FDA guidelines perfectly integrated with IT capabilities.
  • Complete understanding of the complex drug development process, including NCEs, generics, biologics, and biosimilars.
  • Vast experience in working across multiple therapeutic areas like oncology, cardiovascular, psychiatry, respiratory, renal, gastrointestinal, etc.
  • Defined processes of thorough scientific, medical, editorial, and in-house quality control review before the sponsor review.
  • Experience in drafting medical writing documents for various phases of clinical development, including Phase I to IV, Post-marketing Surveillance Studies (PMS), and Post-authorization Safety Studies (PASS).
  • Well-versed in working with various stakeholders alongside Regulatory medical writing teams like clinical operations, data management, biostatistics, medical, and safety to deliver documents.
  • Submission-ready medical writing documents in terms of technicalities, language, format, and templates used to prepare the documents.
  • Timely delivery of medical writing documents with the highest standard of quality.

Ready to elevate your medical content? Our experienced team of medical writers is here to deliver exceptional results. Reach out to us now and let's discuss how we can meet your specific medical writing needs

Contact Freyr