Medical Writing is an indispensable aspect of any Regulatory submission for Pharmaceuticals. Developing precise and accurate clinical and nonclinical documents for any dossiers for Regulatory submissions 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 team is also flexible in adapting to client-specific processes and templates for the development of any documents. The alignment of experts and other team members based on project-specific requirements ensures better time management through an efficient transition to project completion.

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

Full range of MW Services at Freyr


Freyr Expertise

  • Strategic 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 global Regulatory and medical review of advertising and promotional materials.
  • A holistic review of promotional products with compliance management.

Freyr Advantages

  • A team of over forty (40) clinical and nonclinical experts, including scientific writers.
  • In-depth Regulatory 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 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 like clinical operations, data management, biostatistics, medical, and safety teams to deliver documents.
  • Submission-ready documents in terms of technical information, language, format, and templates used to prepare the documents.
  • Timely delivery with the highest standard of quality.
Global HA Mandates