Medical, Scientific and Regulatory Writing

Our Medical Writers have expertise in a wide range of therapeutic areas. They have strong scientific backgrounds and apply indication-specific knowledge to provide accurate and well-written submission-ready documents. Our Medical Writers can assist your company in the development, preparation, and review of documents in support of regulatory submissions and clinical trials.

Medical, Scientific & Regulatory Writing Services include:

  • Investigational New Drug Applications (INDs)
  • Investigator Brochures (IBs)
  • Protocol and Protocol Amendments
  • Clinical Study Reports (CSRs)
  • Safety Narratives
  • IND Annual Reports
  • New Drug Applications (NDAs)
  • Regulatory Briefing Documents
  • Manuscripts for Publication