,End-to-End Medical Writing Services - Overview
At Freyr, we provide medical writing services throughout the drug product development process, tailored to meet your specific needs. We adhere to regulations, maintain good documentation, and provide expertise, technology, and processes. We deliver high-quality documents and Phase I-IV clinical trial services across various therapeutic areas, utilizing advanced strategies and methodologies.
Globally, Freyr has a network of skilled medical writers who analyze and interpret data and develop high-quality documents within specified timelines for country-specific submissions. We utilize tools and resources to enhance document creation, facilitate real-time collaborative reviews, and safeguard data integrity and quality.
End-to-End Medical Writing Services
- 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 along with Integrated Summaries (ISS, ISE, and ISI), 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
- Scientific and clinical justification/response including support for biowaiver claims in product approval and study design strategy
- Response to FDA/EMA queries in line with the EU, US, and other emerging Regulatory markets
- 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, including PDE and OEL calculations
- A team of forty (40) medical writing experts, with experience ranging from 4-25 years, having in-depth Regulatory medical writing knowledge with ICH-GCP, EMA, and FDA guidelines
- Our team exhibits diversified qualifications ranging from pharma postgraduates, physicians, Pharm. D to board-certified toxicologists
- Complete understanding of the complex drug development process, including NCEs, generics, biologics, and biosimilars
- Extensive experience across multiple therapeutic areas with established in-house processes for thorough scientific, medical, editorial, and quality control, plus expert reviews
- Experience in drafting medical documents, including Phases I-IV, Observational/Registry studies, PMS, and PASS
- Experienced in cross-functional collaboration and Regulatory medical writing teams including Clinical Operations, Data Management, Biostatistics, Medical, Non-clinical, and Safety—to ensure timely delivery of medical documents
- Submission-ready medical writing documentation adhering to Regulatory guidance
