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.
- 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.