At our client’s request, we produce quality documents for regulatory affairs and those for medical (non-regulatory) affairs in a timely manner.

Regulatory Affairs

Regulatory Affairs:

  • Protocols
  • Clinical study reports
  • Clinical pharmacology study reports
  • New Drug Application sections
  • Supplemental NDA sections
  • Investigator Brochures and updates
  • IND updates
  • Patient safety narratives
  • Consultation for drug development plans
Medical Affairs

Medical Affairs:

  • Manuscript preparation for peer-reviewed journals
  • Consulting services for new drug development plans, specifically cardiovascular, as well as other therapeutic areas
  • Abstracts and posters for scientific meetings