Regulatory Compliance

A Track Record of Regulatory Excellence

Producing APIs for manufacturers of ethical pharmaceutical products requires a world-class regulatory compliance management system, clean inspection compliance history, a series of licenses governing the handling and transportation of regulated materials, and a thorough understanding of country-by-country restrictions pertaining to the import and export of APIs and finished dosage forms (FDFs).

Purisys holds a 40+ year exemplary track record of successfully managing controlled substance raw materials and controlled APIs in accordance with U.S. and international rules and country-by-country regulations.

Maintaining a global operation with a global workforce, Purisys offers pharmaceutical producers the assurance of carefully documented regulatory compliant processes worldwide, the benefits of fully trained personnel, and the integrity of products produced at our fully registered cGMP production site.

We work with global health and regulatory authorities such as the FDA, EMEA/EDQM, PMDA, TGA, DEA, EPA, OSHA, Health Canada and US Homeland Security, with an exemplary reputation and compliance record undergoing multiple customer and government-related audits on a monthly basis.