Technical and Medical Writing

Technical Writing

We will prepare for you or assist you in preparing various media to communicate the data and results from your study, including both oral and written formats.  All communications will require your final approval. Examples include:

  • IND applications
  • Other submissions to regulatory bodies
  • The preparation and editing of text, figures and tables for manuscripts (also photographs and video clips to be appended, when required).
  • Writing correspondence to journals
  • Creating lay summaries of research, grants, etc. for press releases
  • Preparing PowerPoint presentations for teaching, invited lectures, talks at meetings, etc.
  • Creating posters for scientific and clinical meetings
  • Other communications as needed

Medical Writing

Specific services available for your organization include:

Clinical Development, Regulatory Communications, Medical Writing

  • Interpret FDA policies and guidelines
  • Develop U.S. labeling (e.g., physican and patient package inserts, cartons and vials)
  • Direct FDA Advisory Committee preparations, briefing documents and presentations
  • Provide regulatory input to the marketing promotional materials review process
  • Medical writing, compilation and/or detailed critical reviews of all aspects of regulatory submissions and communications
  • Present or prepare presentations for investors and Boards involving development of drugs, biologics, or combination products
B2S Life Sciences