Medical Writing 

We will not only help you write the typical clinical development documents such as protocols, clinical study reports (CSRs), and Investigator’s Brochures, we are experienced in preparing regulatory documents to support drug, biologics, device, and diagnostic submissions to regulatory agencies worldwide. We understand the complexities of writing in a highly regulated environment and the challenges of varied requirements of different regulatory agencies.

Core Medical Writing Services

We provide medical writing support for all phases of development for indications ranging from rare genetic diseases to large global vaccine trials. We offer rapid turnaround to meet tight timelines, and flexible, efficient processes for any project large or small. Using in-house or sponsor-supplied document templates, we apply best practices for content, format, and style to meet global technical requirements.   We help you write:
  • Clinical Development Plans
  • Investigator Brochures
  • Protocols
  • Data Safety Monitoring Board charters
  • Clinical Study Reports (CSRs)
  • Safety narratives
  • Annual reports (eg, PSURs, DSURs, PBRERs)
  • Regulatory briefing documents (eg, End-of-Phase 1, End-of-Phase 2, Pre-NDA and Advisory Committee)
  • Regulatory Submissions in eCTD format (all phases; including IND, CTA, NDA/sNDA, MAA, NDS, JNDA)



Ancillary Medical Writing Support

  • Slide presentations for conferences, FDA Drug Advisory Committee meetings, CHMP Oral Explanations, and other regulatory meetings
  • Abstracts for professional meetings and Manuscripts
  • Clinical trial registration and results postings
  • White papers
  • Literature reviews

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