Quality, Accreditations, and Facilities

Clinigen Clinical Supplies Management is consistently delivering quality-minded results for your clinical trials, and we hold the relevant and mandatory licenses, authorisations, and accreditations. We have a genuine interest in the well-being of others, providing clients with the highest level of standards, ethics, and quality. Our quality is by design, requiring stringent QA oversight from start to finish with all necessary quality checks during each process. Our Quality System demonstrates our commitment to quality and is proven by the hundreds of successful client audits of our global sites.

OUR Accreditations:

• cGMP Facilities
• EU GMP Manufacturing & Import Authorisations (MIA)
• EU GMP Certificates
• NABP Accredited Drug Distributor / Wholesale Lincenses WDA(H)
• Wholesale Drug Distributor
• DEA Registered

Facilities & Equipment

Clinigen's facilities and equipment are customised for the packaging & labelling, storage, and distribution of clinical supplies and scaled for the needs of clinical studies of all phases, from small but complex Phase I studies to high volume Phase III studies, as well as Phase IV studies. At our dedicated GMP sites in the US and EU, we manage the clinical trial supplies process for hundreds of clinical studies worldwide. All facilities and equipment have been fully validated/qualified and calibrated.

Our team maintains 24/7/365 environmental monitoring and security to ensure our clients' materials are safe and stored properly.

Clinigen CLinical SUpplies Management Facilities & Locations