When it comes to the complex regulatory environment of controlled substances, experience matters. Patheon has established its leadership in the field since 1974, and some of our key staff with more than 30 years of experience working with the U.S. DEA and other international enforcement agencies. The special challenges of controlled substances can be overwhelming, but Patheon has all the infrastructure and licensing in place to give your company access to this segment of the market.
Schedule CI-CV Registrations for development, manufacturing, analytical & stability testing, packaging, distribution and import/export activities.
Physical Security Infrastructure including storage vaults, alarm systems & CCTV monitoring.
Strict Accountability incorporated into procedures, recordkeeping and reporting
Quota Submission & Management for Schedule CI-CII and regulated List 1 Chemicals.
Patheon has a deep understanding of the application process and the information required to keep a project moving forward with minimal delays. With fully integrated facilities, we can quickly and efficiently move your controlled pharmaceutical products through development to commercialization.