Compliance Architects® is a proven partner in REMS audit services, delivering custom-tailored solutions to fit each client. Our agile approach is designed to meet the complexity, requirements, and multi-party involvement of REMS audits — and we’ve demonstrated consistent success in helping sponsors remain compliant.
FDA conducts inspections to evaluate compliance with risk evaluation and mitigation strategies (REMS) requirements, ensuring that a drug’s benefits outweigh its risks. Because these inspections are prioritized using a risk-based approach, REMS audits differ significantly from “typical” site audits and demand specialized expertise.
The REMS process often includes:
Compliance Architects® is a proven partner in REMS audit services, delivering custom-tailored solutions to fit each client. Our agile approach is designed to meet the complexity, requirements, and multi-party involvement of REMS audits — and we’ve demonstrated consistent success in helping sponsors remain compliant.
Successful commercialization requires more than meeting regulator requirements and expectations alone. We provide end-to-end project management support to ensure your products are advanced from concept to market. By partnering with us, your team benefits from experienced project managers, regulatory experts, and commercialization operators who oversee every facet of the commercialization process, ensuring it stays on track and in alignment with your business expectations.
Our commercialization project management services include:
The FDA will take enforcement action if issues found during REMS inspections are not promptly corrected. Failure to comply may result in product seizure, injunctions, civil penalties, or warning letters. FDA also reviews REMS assessment reports to evaluate ongoing compliance and may issue regulatory actions to mitigate serious patient safety risks.
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