PLG’s vigilance and medical-writing service for biotech clients recommends the best way to establish and maintain a pharmacovigilance system, monitor adverse events, and prepare medical documentation—from clinical stages to product commercialization.

 

Deliverables:

  • Good-pharmacovigilance-practices-compliant pharmacovigilance system
  • Aggregate reports such as the Development Safety Update Report (DSUR), periodic safety update report (PSUR), and risk management plan (RMP)
  • Preclinical and clinical documentation (e.g., CTD, Modules 4 and 5, and summaries) writing and review
  • Briefing packages for scientific advice
  • Investigation brochures
  • Toxicology expertise
  • Clinical-study report writing and review
  • Product information (e.g., CCDS, SmPC, medical information materials)

 

Learn more about our Vigilance and Medical information Center of Excellence.