Specialized in Scientific, Clinical, Medical Writing.

Global PharmaTek offers a wide range of services in Writing services spanning from individual documents to extensive medical writing programs. Expertise teams to provide high quality medical writing services for the biotech, pharmaceutical and medical devices companies across the globe.

Our Focus Areas

Scientific Writing

  • Medical educational and training materials
  • Medical marketing reviews and reports
  • Literature reviews
  • Publication planning
  • Abstracts, Manuscript, Posters, Brochures and Slides
  • Journal/conference submission

Regulatory Writing

  • CTD/eCTDs,
  • INDs, IDEs, NDAs, ANDAs, BLAs, PMA, MAA
  • CMC/manufacturing reports

Safety Writing

  • AE/SAE Narratives
  • Causality Assessments
  • Analysis of Similar Events
  • Aggregate periodic safety reporting (PADER, PSUR/PBRER, ASR/DSUR)
  • ICSR narratives
  • Dear HCP letters
  • Risk benefit assessments
  • Guided Questionnaire
  • Signal Evaluation reports
  • Health hazard evaluations

Clinical Writing

  • Clinical study reports
  • Informed Consent forms
  • Clinical Study Protocols, SOPs, Templates
  • Case Report Forms (CRFs)
  • Investigator brochures (IBs)
  • Clinical Development Plans (CDPs)
  • Orphan Drug Designation (ODD)