ISO 9001:2015   |   ISO 27001:2013

Medical Writing

Our highly experienced team of medical writers work on a variety of projects. We research the competition, navigate through the intricacies of your drug profile and provide a high quality, clinically meaningful report. Every research report is a stepping stone towards a quality submission and every quality submission is a well structured path to a promising approval.

Our expertise in providing quality documents includes the following:

Clinical Documents

  • Protocols
  • Case Report Forms (CRFs)
  • Investigator Brochures
  • Clinical Study Reports (Phase 1-4)
  • Consent forms/Patient information
  • Position papers
  • Safety narratives/summaries
  • Query responses from regulators

Regulatory Documents

  • Product Monographs & Core Data Sheets (CDS)
  • Risk Management Plans (RMP)
  • Patient Package Inserts/Medication Guides
  • Summary of Product Characteristics (SmPCs)
  • INDs, NDAs, MAAs and other international drug submissions
  • Briefing documents for agency meetings
  • Orphan drug applications
  • Requests for fast track designation

Pharmacovigilance Documents

  • Periodic Safety Update Reports (PSURs)
  • Special safety reports
  • Expert Overviews/Reports

Publications and Other Documents

  • Manuscript preparation
  • Posters and platform presentations
  • Field force training documents and slides
  • AMCP dossiers
  • Regulatory guidance and review of advertising/promotional materials
  • Trial Disclosure Services

Regulatory Submission Support Based on Strong Science and Strength of Process. The difference is in the data!