Consultative services for commercial manufacturing

The expertise to navigate complexity

Partner with us to leverage our wide-ranging scientific expertise and proven track record in regulatory support for chemistry, manufacturing and controls (CMC). We deliver quality assurance services essential to every stage of commercial manufacturing, including process validation and marketing applications.

Our experienced team works closely with customers throughout each project, with primary offerings including process and compliance management, assistance with filing and agency correspondence, and ongoing quality assurance. We’re proud of our track record of quality, as proven through compliance with the FDA, AIFA, PMDA and other regulatory agencies and more than 200 API dossiers filed worldwide.