Medical Writing

If you ask any regulatory authority assessor what makes their job difficult, they will all say poorly written dossiers! The result is more regulatory agency questions and potential delays in approval. At RRG we have experience with writing over 500 dossiers and have trained hundreds of regulatory and scientific staff on dossier writing skills. RRG has a team of highly experienced regulatory and scientific experts covering CMC, nonclinical and clinical areas.

Our goal is to:

  • Present data clearly and concisely
  • Communicate science effectively
  • Ensure correct level of detail is included to minimise questions during approval and number of variations post approval
  • Ensure compliance with all regulatory requirements

We can prepare:

  • All Modules for the CTD
  • Summaries and Overviews
  • Authority Meeting Briefing Packages
  • Responses to regulatory authority questions
  • IMPDs
  • INDs
  • Investigator Brochures
  • PSURs
  • Environmental Risk Assessments
  • Medical Device dossiers

Contact Us

T: +44 (0)1276 671 166
F: +44 (0)1276 670 960
info@rrgconsultancy.com

Email Us

Find Us

RRG, Innovation House
Albany Park, Camberley
Surrey. GU16 7PL

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