Writing is an artform often celebrated in popular culture but is somewhat underrated and taken for granted in medical research and development. And yet clinical research must be written to the highest possible editorial and scientific standard in the pursuit of bringing a medicinal product to market.

Regulatory Documentation

All written documents must pass through the rigour of regulatory body and journal scrutiny. Scientific accuracy, grammatical correctness, and a simple and effective writing style contribute to the integrity of every single document created for regulatory, healthcare professional and public consumption.

Regulatory agencies analyse all regulatory documents with a keen eye, spotting errors and inconsistencies that can reduce the integrity of a submission. Any delays in the submissions process can be expensive for biopharma companies in terms of time and money required to rectify errors, and the knock-on delay of attaining marketing authorisation applications, leading to a delay in future revenue.

Our team of regulatory medical writers adhere to industry guidelines and standards, to faithfully and ethically report your clinical trial data, recognising how important these documents are to your healthcare and business objectives. We can manage the entire lifecycle of the various regulatory documents that make up your submissions, including:

  • Clinical study reports
  • Clinical study protocols
  • Clinical evaluation reports
  • Clinical and pre-clinical electronic common technical document modules
  • Clinical sections of new drug applications
  • Investigator brochures
  • Clinical summaries and overviews
  • Preclinical study reports, expert reports, and summaries
  • Non‑clinical summaries and overviews
  • Patient narratives
  • Informed consent forms
  • Case report forms
  • Standard operating procedures

Pharmacovigilance

The reporting of safety data is integral to a products regulatory documentation. We are experienced in delivering a range of pharmacovigilance documents, including:

  • Periodic safety update reports
  • Development safety update reports
  • Periodic benefit-risk evaluation report
  • Benefit/risk assessment reports
  • Data safety monitoring board manuals
  • Risk management plans

Get in touch to learn how we can help you!