Pharmacovigilance, Regulatory and CMC Support

Our comprehensive regulatory services support your product throughout its entire lifecycle, from initial submission to post-approval management. We provide end-to-end administrative support including filing, addressing Requests for Further Information, and managing applications through to Marketing Authorization grant. Our expertise spans Module 1 compilation, Environmental Risk Assessment preparation, and thorough review of Modules 1-5, ensuring your dossier meets all regulatory standards. For patient-centric requirements, we conduct Patient Information Leaflet user testing and bridging studies to ensure clarity and compliance. Our pharmacovigilance capabilities include PSMF and RMP preparation alongside dedicated UK/EU QPPV support for ongoing safety monitoring. Beyond approval, we provide complete lifecycle management to maintain compliance and support variations, renewals, and regulatory updates throughout your product's commercial life