Regulatory Capabilities

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 Chemical, Manufacturing and Controls (CMC) requirements to support approvals in those markets.

Our experience with global health and regulatory authorities includes the FDA, DEA, EMEA/EDQM, PMDA, TGA, EPA, OSHA, and Health Canada. We have an exemplary reputation and compliance record, all backed by ongoing audits.

We have compliance expertise with the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes, including fully synthetic pathway review and nitrosamines analysis. 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.

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