Regulatory Services

At Purisys, we offer broad regulatory experience encompassing preclinical to IND/INMD to NDA/ANDA phases. We work around the world with individual country regulatory CMC requirements to support approvals in those markets.

As part of our custom synthesis offering, outputs of development and manufacturing are assembled into a CMC format for organization and seamless transfer in regulatory filings. Our reference standards and associated analytical packages stand up to regulatory review by health authorities around the world. These health authorities routinely procure reference standards from Purisys for internal use.