Overview

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 the quality checks, and accomplishes the project management of various Regulatory, clinical and medical writing activities. The Freyr medical writing team, with a proven proficiency in developing and delivering world-class Regulatory and medical writing services for its growing clientele of (global large) Pharma, leading CROs and other Biotech companies adheres to stringent timelines and high-quality parameters. 

Freyr is a preferred global medical writing services provider for writing, performing independent quality review and identifying gaps/performing gap analysis in already prepared/compiled dossier.

 

 

Freyr Expertise

  • 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 clinical part of the dossier
  • Biowaiver support and providing justification document services
  • Handling and responding to health authority queries
 

Freyr Advantages

  • 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 in‑house 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