Medical Writing is a vital segment of clinical research. It plays a critical role in the development and submission of clinical research documents and defines the success or failure of new medicinal products/devices. As Regulatory authorities expect precise and timely submissions of documents/dossier, any delay in this stage leads directly to a delay in realizing profits both in terms of achieving patient benefit and ROI.
With a qualified (Medical and Paramedical) team of skilled and experienced medical writing professionals from pharmaceutical and clinical research industries, Freyr develops quality documents, performs peer review and coordinates client reviews, performs quality checks, and accomplishes the project management of various Regulatory, clinical writing activities in both Electronic Common Technical Document (eCTD) and CTD modules. The Freyr medical writing team has proven proficiency in developing and delivering world-class Regulatory medical and scientific writing services for its growing clientele of (global large) Pharma, leading CROs and other Biotech companies adhering to stringent timelines and high-quality parameters. Freyr also ensures that the writing is in line with the corresponding clinical research.
Freyr is a preferred global Regulatory writing services provider for writing, performing independent quality review, conducting thorough technical review of dossiers and identifying gaps/performing gap analysis in already prepared/compiled dossier. Our Regulatory medical writing professionals can cater to the needs of various regional Health Authorities (HAs) of North America, EU, Middle East and North Atlantic region, and other APAC nations including India, China, and Philippines.
- Clinical overviews (eCTD Module 2.5) including literature review and references
- Clinical summaries (eCTD Module 2.7) including clinical pharmacology, efficacy, and safety
- Clinical study report preparation and review (eCTD Module 5)
- Clinical justification documents for EU, US and other emerging Regulatory markets
- Gap analysis for dossiers in clinical part
- Biowaiver support and providing justification document services
- Providing clinical and nonclinical document support, handling queries during HA meetings and responding to them
- Technical review dossiers
- Strategic support for study design
- In-depth Regulatory knowledge 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 quality control review inhouse prior to the sponsor review
- Experience in writing documents for various phases of clinical development including Phase I to Phase IV, post-marketing surveillance studies (PMS) and post-authorization safety studies (PASS)
- Well-versed in working with various stakeholders like clinical operations, data management, bio-statistics, medical and safety teams to deliver documents
- Submission ready documents in terms of technical information, language, format and template used to prepare the document.
- Timely delivery with the highest standard of quality