Our experience includes preparation of:
- Safety information reviews & revisions
- All sections of medical assessments
- Full safety profiles
- Risk-related position papers
- Risk-benefit evaluations
- Integrated summaries of safety (ISS)
- Product expectedness lists
Our safety experts are also qualified to assist you with:
- Oversight and Tracking of Medical Monitoring
- Thorough Literature Searches and Assessments of Epidemiology
- Identification of Significant Risks and Missing Information
- Reviewing and Determining Adequate Routine and Additional Risk Minimization Measures
- Creation of Submission-Ready RMPs
- Assessment checks to document the effectiveness of risk mitigation strategies