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.

Medical Writing Services for Clinical Trials & Regulatory Submissions

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 with:

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/Publication article writing
  • Literature reviews

Writing Multiple Marketing Applications At The Same Time

Learn how our medical writing team helped a recent client  write their New Drug Application, Marketing Authorization Application and New Drug Submission at the same time with accelerated timelines since the product received Orphan Drug Designation in the United States and Europe and Priority Review status in Canada.   


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