The FDA requires REMS for drugs with serious safety concerns where benefits still outweigh risks. These complex programs demand extraordinary controls—restricted distribution, prescriber certification, patient monitoring, and detailed reporting. REMS failures jeopardize patient safety and product availability. FDA enforcement can include program modifications, additional restrictions, or product withdrawal.
REMS compliance requires orchestrating multiple stakeholders—manufacturers, distributors, prescribers, pharmacies, and patients. Each must follow specific requirements while data flows seamlessly for monitoring and reporting. Success demands both robust systems and flawless execution.
Our REMS auditors understand these complex programs from design through implementation. We evaluate both compliance elements and effectiveness measures to ensure your REMS achieves its safety objectives.
Is your team using Veeva as your eQMS? In addition to conducting audits, we can complete your data entry directly within your Veeva system, saving you significant time and attention.
Our dedicated project support team works directly with our auditors to streamline the process of inputting audit reports into the Veeva platform. We’ll guide your Veeva Administrator through the steps to confer the necessary user permissions in the platform and take care of the audit input on your behalf.
Contact us to learn more about integrating Veeva management into your auditing service so you can focus on your core operations.