Expert CMC & Regulatory Support for Drug Development

How Fluorochem Supports You

Navigating the complexities of pharmaceutical development requires expert Chemistry, Manufacturing and Controls (CMC) and regulatory alignment. Satisfying these requirements can be a resource-intensive and challenging process, inextricably linked with technical development and production efforts. Meticulous validation and documentation of manufacturing processes, drug characteristics, and testing of intermediates, through each phase of the molecule’s lifecycle, are essential for regulatory compliance and consistent quality.

As trusted and reliable Contract Development and Manufacturing Organization, ChemExpress ensure your drug development program meets global regulatory standards from preclinical to commercial stages. A professional CMC team provides an integrated and ongoing approach that supports documentation, compliance and technical validation, reducing time to market and risks by maintaining quality and safety.

Benefit from their experience in CMC and regulatory filings as your API moves from IND to NDA or BLA. With a demonstrated track record in regulatory alignment for varied pharmaceuticals, including small molecule drugs, antibodies and peptides and regulatory expertise in finished drug products, including formulation and excipients. Avoid costly delays and regulatory pitfalls with dedicated experts who understand evolving guidelines and expectations of global licensing agencies. Partner with us to accelerate your pharmaceutical innovation with confidence and compliance at every step.