Regulatory Medical Writing Services - Overview
Regulatory Medical Writing is an indispensable aspect of any Regulatory submission for pharmaceuticals. Developing accurate Clinical and Non-clinical 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 player in Regulatory Medical Writing Services and has vast expertise due to a team of highly qualified medical and scientific writing professionals. At Freyr, well-established processes governed by SOPs, checklists, and reviews ensure that high-quality documents are maintained. 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 Medical Writing experts and other team members based on project-specific requirements ensures better time management through an efficient transition to project completion.
Our Medical Writing team is well-versed in dealing with submissions for the US FDA, EMA, MHRA, and other regulated and semi-regulated countries.
Freyr’s Regulatory Medical Writing Services
Regulatory Medical Writing Services
- Strategic Regulatory Writing that supports Clinical and Non-clinical Development according to the submission type and health authority
- 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, extractable and leachables, excipients, and industrial chemicals
- Permitted Daily Exposure (PDE) and Occupational Exposure Level (OEL) calculations
- A team of over sixty (60) Medical Writing experts, which includes clinical, non-clinical, and scientific writers
- In-depth Regulatory Medical Writing knowledge like the ICH-GCP, EMA, and FDA guidelines is perfectly integrated with IT capabilities
- A 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
Medical Writing
