Clinical Regulatory Document Writing for Submission.

Therapeutic Areas

Our Experience is Unmatched

Regulatory submission planning requires an in-depth knowledge of clinical research and development, and our Medical Writing Group and QC team collectively has over 100 years of experience.

Our writers have a wealth of expertise that crosses all aspects of regulatory submissions and many therapeutic areas.

For clinical protocols, study reports, New Drug Applications (NDAs), and Biological Licensing Agreements (BLAs), count on PreciseDox for an unparalleled writing experience.

Our writers:

  • Understand clinical data, how to interpret and present it
  • Respect and meet client timelines
  • Provide valuable insight at each step of the process
  • Are versed in ICH regulatory requirements
  • Are GCP experts

A brief listing of several therapeutic areas where our writers offer in-depth knowledge and experience:

  • Oncology
  • Cardiovascular Medicine
  • Chronic Kidney Disease
  • Pain Management
  • Central Nervous System
  • Anti-infectives
  • Gastrointestinal
  • Vaccines
  • Metabolic Disease
  • Immunotherapy
  • Drug Delivery
  • Orphan Diseases

To learn more about how we can help your organization or request a quotation, please call us at 610-296-1747.