PSUR, RMP and other Safety Reports
Pharmacovigilance
Pharmacovigilance legislation requires MAHs to submit periodic and risk-based safety reports to assess the benefit-risk profile of their medicinal products. These documents must be scientifically robust, up to date, and fully aligned with global regulatory requirements.
We prepare and review key pharmacovigilance documents such as PSURs, RMPs, and ad-hoc safety reports, ensuring compliance with EMA, FDA, and other Health Authorities.
Our team provides scientific and regulatory support throughout the process, from data analysis to submission.
Our services include:
- Periodic Safety Update Reports (PSUR / PBRER): Compilation of cumulative safety data, analysis of benefit-risk balance, and regulatory submissions in accordance with ICH E2C(R2).
- Risk Management Plans (RMPs): Creation and updates of RMPs following GVP Module V, including safety specifications, pharmacovigilance plans, and risk minimization measures.
- Addendum to Clinical Overviews (ACOs): Prepared for EU marketing authorization applications when required.
- Ad-hoc Safety Reports: including safety summaries for regulatory queries, and safety sections for renewals or variations.
