Medical Writing for Clinical Trials and Regulatory Submissions

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:

Clinical Development Plan writing
Investigator Brochure writing
Protocol writing
Data Safety Monitoring Board (DSMB) Charter writing
Clinical Study Reports (CSRs) writing

Writing Multiple Marketing Applications At The Same Time

A Regulatory Submission Success Story

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.