Medical Writing

Regulatory Medical Writing

The term medical writing refers to the writing of scientific and medical texts and publications. Medical writing also serves the purpose of effectively communicating clinical and scientific data as well as scientific information.

The process of medical writing requires deep knowledge of product development, the legal and technical principles of clinical trials as well as the current regulatory practice requirements. Only clearly structured, precise and targeted presentations produce contextually correct documents of the highest standard.

Regulatory Medical Writers must bridge the distance between Research & Development (R&D) and Pharma and Scientific Marketing. Knowledge of both science and research must be combined with an understanding of how to present information effectively in order to reach the right level for the intended audience. A professional level of English is a must, as well as keen attention to detail. Our medical writers at DREHM have a rich educational background with doctorates in life sciences (e.g., veterinary and human medicine) coupled with excellent writing and language skills.

How does DREHM Pharma support you with Medical Writing?

Team Medical Writing [Meet the Team!][8]

Team Medical Writing Meet the Team!

Our experts assist you with their medical training in the preparation of the following documents:

  • Scientific and medical texts
  • Expert reports for preclinical and clinical studies (CTD modules 2.4 to 2.7)
  • Literature searches
  • Review of existing documentation on eligibility for marketing authorization approvals
  • Clinical evaluation of medicines and medical devices
  • Summary of Product Characteristics (SmPC) and patient information leaflets (PIL)
  • Medical opinions
  • Specialized medical and scientific translations
  • PIP (waiver) applications
  • Orphan drug applications
  • Risk Management Plans (RMP)

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We like to share our extensive experience with you!