,Regulatory Medical Writing Services - Overview
Medical writing is an indispensable aspect of any Regulatory submission for Pharmaceuticals. Handing clinical and non-clinical modules for Regulatory submission dossiers under medical writing requires an in-depth understanding, experience, and thorough Regulatory knowledge.
Freyr is a significant player in offering Regulatory Medical Writing Services and has expertise due to a team of highly qualified medical writing professionals. Our well-established processes governed by SOPs, checklists, and reviews ensure that high-quality documents are maintained. Our Regulatory medical writing team is flexible in adapting to client-specific processes and templates for developing documents. Such experts' alignment based on project-specific requirements ensures better time management in project completion.
Our Regulatory writing services team is equipped to work with the US, EU, UK, and other regulated and semi-regulated countries.
Freyr’s Regulatory Medical Writing Services
Regulatory Medical Writing Services
- Preparation and review of Non-Clinical and Clinical Overviews and Summaries (eCTD Modules 2.4, 2.5, 2.6, and 2.7), including the preparation and review of eCTD Modules 4 and 5
- Preparation and review of the Clinical Study Report (CSR, eCTD Module 5)
- Preparation and review of the Clinical Trial Protocol (CTP), Investigator Brochure (IB), efficacy and safety summaries, and patient/safety narrative writing
- Support for 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
- Abuse liability assessment justification support
- Clinical (GCP) and bioanalytical (GLP) facility audits provide expertise and support for study-specific monitoring
- Toxicological Risk Assessment (TRA) of impurities, extractables and leachables, excipients, and industrial chemicals
- Permitted Daily Exposure (PDE) and Occupational Exposure Level (OEL) calculations
- A team of over sixty (60) clinical and non-clinical medical writing experts
- In-depth Regulatory medical writing knowledge, like the ICH-GCP, EMA, and FDA guidelines, with IT capabilities integration
- Vast experience in 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)
- Timely delivery of medical writing documents with the highest standard of quality
Medical Writing
