We provide strategic advice and planning of regulatory CMC submissions at both pre- and post- marketing phases based on global regulatory requirements.

We conduct procedural and submissions reviews to identify gaps and inconsistencies. We perform assessments in light with global regulatory requirements, so sponsors can feel confident about their submissions.

We work with manufacturers and sponsors to fulfill any CMC-specific commitments made with the Health Authorities and help establish CMC conformance as a key element to maintain CMC compliance.