Services
Independent medical consulting for pharmaceutical and biotechnology companies across clinical development and pharmacovigilance. Consulting services are primarily provided remotely. On-site support can be arranged for selected projects where it adds value.
Clinical Safety & Pharmacovigilance
Independent medical expertise across the product lifecycle
- Medical Review
- Individual Case Safety Report (ICSR) Review
- Signal Management
- Benefit–Risk Assessment
- Safety Data Interpretation
- Aggregate Reports (PSUR / PBRER / DSUR)
- Risk Management Plans (Medical Review)
- Cross-functional Medical Support
Medical Writing
Scientific and regulatory medical documentation
- Safety Narratives
- Scientific Medical Writing
- Clinical Safety Documentation
- Regulatory Safety Documentation
- Aggregate Safety Reports
- Benefit–Risk Documentation