CMC–Regulatory Support

Our custom CMC-Regulatory services help clients align their CMC regulatory strategy and corporate strategy, while ensuring regulatory compliance.  Our team prides itself on staying apprised of current FDA, Health Canada and EMA regulatory requirements and guidances. We understand regulator expectations and interpret guidance documents with knowledge and first-hand experience, allowing us to provide unique and creative CMC-regulatory solutions that consider both the product specific needs and corresponding regulatory requirements. By identifying gaps, critical path activities and reducing risk, AspireBio can help expedite the development of your product(s) at any phase.