Quality Is Our Top Concern
PDH operates its facilities to comply with the highest quality standards required for the markets it serves. Our focus on quality ensures our customers products are not only consistent from each lot supplied, but also meet and exceed the regulatory requirements of the markets they supply.
Our production sites have been audited and certified, where applicable, by organizations with the highest regulatory standards in the world, including:
The Medical Products Agency, Sweden, based upon Part 1 drug standards for EU certification
Manufacturing Site GMP Approval by German Authorities as identified by the Pharmaceutical Products Act
USA FDA audits against CFR 210/211 standards
The company-wide dedication to Quality is crucial to PDH’s ability to comply with some of the strictest regulatory agencies in the world.