End-to-End Medical Writing - Overview
At Freyr, we offer end-to-end medical writing services across the drug product development lifecycle with a customized work model. We ensure adherence to regulations, maintain good documentation practices, and provide a comprehensive range of technology, processes, and expertise. We aim to deliver quality documents, and Phase I-IV clinical trial services, across various therapeutic areas with advanced clinical strategies.
Globally our skilled workforce in the medical writing process; works to analyze and interpret data and develop quality documents within specified timelines. We utilize tools and resources to enhance document creation, facilitate collaborative reviews in real time, and safeguard data integrity and quality.
End-to-End Medical Writing
- Strategic Regulatory medical writing support for clinical and non-clinical development according to the submission type and health authority
- Preparation and review of nonclinical & clinical overviews and summaries (Module-based) and the preparation and review of eCTD Modules 4 and 5.
- Preparation and review of Clinical Study Report, Clinical Trial Protocol (CTP), Investigator Brochure (IB), briefing packages, efficacy and safety summaries, and patient/safety narrative writing.
- Preparation of Plain language Protocol Synopsis (PLPS) and Plain Language Summaries (PLS) for EU submissions.
- Support for EU-CTR services.
- Support on Integrated Summaries (ISS, ISE, and ISI).
- Scientific and clinical justification/response to FDA/EMA queries in line with the EU, US, and other emerging Regulatory markets.
- Support to claim biowaiver in context to product approval and strategic support for study design.
- Expertise in conducting Clinical (GCP), bioanalytical (GLP) facility, and medical writing audits and support in study-specific monitoring.
- Expert-driven non-clinical assessments that include Toxicological Risk Assessment (TRA) of impurities, extractables & leachables, excipients, and industrial chemicals.
- Permitted Daily Exposure (PDE) and Occupational Exposure Level (OEL) calculations.
- A team of forty (40) medical writing experts, which includes clinical and non-clinical experts.
- In-depth Regulatory medical writing knowledge with continuous learning and upgradation with ICH-GCP, EMA, and FDA guidelines.
- Complete understanding of the complex drug development process, including NCEs, generics, biologics, and biosimilars.
- Vast experience in working across multiple therapeutic areas and defined in-house processes to ensure thorough scientific, medical, editorial, and quality control, and expert reviews.
- Experience in drafting medical writing documents including Phases I to IV, Observational/Registry studies, Post-marketing Surveillance Studies (PMS), and Post-authorization Safety Studies (PASS).
- Well-versed in working with various stakeholders alongside Regulatory medical writing teams such as Clinical Operations, Data management, Biostatistics, Medical, Non-clinical, and Safety to ensure timely delivery of medical writing documents.
- Submission-ready medical writing documents complete for technicalities, language, format, style, and templates adhering to Regulatory guidance.
