All Corden PharmaChem operations are monitored on a very strict regulatory regime according to industry and national standards. Its processes are executed in accordance with cGMP and ISO 9001:2000 requirements and the facilities are FDA, IMB, TGA and KFDA approved.

Approvals and Inspections

• FDA has carried both pre-Approval and general cGMP Inspections on several occasions since 1990.
• The company has also been inspected and licensed by the Irish Medicines Board for compliance to current Good Manufacturing Practice and to ICH guidelines.
• Within the company a specialist team exists to ensures that all aspects of our processes comply with current international regulatory requirements and that developing technologies and new guidelines are monitored to ensure that current best practice is employed to implementation of effective quality systems and continues regulatory compliance. This team is also responsible for the timely submission and update of Drug Master Files & CEP’S.
• Currently there are more than 100 active DMF’s registered in 28 territories throughout the world including most of Europe, USA, Canada, & Australia.
• The company is routinely inspected by different customers to ensure that all aspects of our registered documentation and procedures are in line with cGMP requirements.