Regulatory Submissions and/or Presentations

Wendy Stephenson & Associates will provide advice and assistance for the preparation of safety-related submissions to regulatory authorities, including for example:

• Development Safety Update Reports (DSUR,e.g., IND Annual Report, EU Annual Safety Report for clinical trials)
• Integrated Summaries of Safety for Marketing Authorization Applications
• Periodic Safety Update Reports for marketed products (PSUR)
• Pharmacovigilance Plans (PVP)
• Risk Management Plans, pre- and post-approval (DRMP, RMP)
• Risk Minimization Action Plans (RiskMAP)

• Risk Evaluation and Mitigation Strategies (REMS)

• White papers in response to specific safety issues or regulatory queries
• Presentations to regulatory authorities (e.g., FDA Advisory Committees)