Our team is ready to scale up or down resources to match your needs, allowing for business continuity and regulatory compliance.
With a proven track record of preparing over 1500 aggregate reports and risk management plans (RMPs) each year, our experts can handle all Aggregate Safety Reporting (ASRs) obligations during clinical development, before the first clock-stop and after the first global marketing authorization.
We have prepared integrated reports to serve numerous territories and varying levels of clinical R&D and registration by changing for example the DSUR DLP to coincide with the International Birth Date (IBD) of a marketed product which undergoes clinical development, to synchronize the DSUR and the PSUR.
We have been involved in the preparation of:
- Development Safety Update Reports (DSURs) that can be either product- or study-specific e.g., in combination therapies
- Periodic Safety Update Reports (PSURs) for medicines and medical devices
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Periodic Adverse Drug Experience Reports (PADERs) or Addendum to the Clinical Overviews (AddCOs) seeking to inform module 2.5 for MA renewals
- RMPs and RMP maintenance in different jurisdictions, using the EU-RMP template and region-specific appendices, such as the GB/UK- and Australia-specific annex (ASA) and addenda serving submissions in Canada and Singapore
- Risk Evaluation and Mitigation Strategies (REMS), REMS revisions and minor or major modifications, affecting medication guides, Elements To Assure Safe Use (ETASUs) and communication plans, submitted as post-authorization studies (PAS)
- Risk evaluations as part of Clinical Evaluation Reports (CER) and ‘inform’ post-market clinical follow-up (PMCF) plans of medical devices.
We have the knowledge to provide efficiencies and streamline processes across multiple jurisdictions. Our PV experts will:
- Lead or support the risk management planning in both pre- and peri-approval and post-market settings
- Help navigate the development of risk minimization measures (RMM), either routine or additional, with an implementation scheme, specific tool recommendations and an evaluation strategy
- Align your risk mitigation processes across multiple geographies of different regulatory frameworks following a careful evaluation of the benefit-risk balance of your products and ascertaining whether product safety information changes are required.