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  • +44 203 514 6741
  • 4 St Nicholas Road, Hertfordshire, AL5 4DF
  • +91 81252 61010
  • Lorven Arcade, Hitech City road, Hyderabad
London Office

Medical/Device Writing

Medical Writing

CBS Writers ensure complete and accurate representation of all aspects of the study and its results while bonding to timelines.

The integrated clinical reports are prepared according to ICH E3 guidelines and format, or according to the sponsor’s specific format. The final documents can be published compliant to the requirements for an eCTD submission.

CBS has vast experience and expertise but not limited to the following:

  • Non-Clinical / Clinical / Regulatory Writing
  • Abstracts, Posters, Slide Sets, Manuscripts
  • Post-Marketing Support Documentation
  • Pharmacovigilance and Drug Safety Reports
  • Risk Management Plan (RMP)
  • Risk Evaluation and Mitigation Strategies (REMS)

Medical Device Writing Services

CBS has vast experience and expertise but not limited to the following:

  • US Regulatory submissions (510(k), PMA, 180 Day, 30 Day Notices, RTR, IDE, Compassionate Use, HUD, HDE, CFG)
  • EU Technical Files, CE Renewals and Change Notifications
  • ROW Market Support
  • Literature search and authoring full product Clinical Evaluation Reports (CERs) with the new MEDDEV 2.7.1 rev 4 guidance
  • Providing updates to CERs post review yearly
  • Gap Analysis, Due Diligence, PMS Plans
  • Labeling Review, Renewals, Updates
  • Narratives Writing
  • Post-Marketing Clinical Follow-Up (PMCFs) / Registry Studies