Throughout the production journey from starting materials to GMP storage, and eventual administration to the patient, a drug product will contact manufacturing components including packaging systems, delivery devices, and in-use components. These interactions may result in the migration of substances (leachables) from these materials into the drug product. Our specialists have extensive knowledge in extractable and leachable assessments and can provide this service to support your product submission.

We offer nitrosamine testing per regulatory requirements with services including Risk Assessment, Testing and Mitigation.

Our experts can also provide comprehensive analytical services for 3-MCPD and GE Testing, utilising both internationally recognised methods and unique in-house analytical approaches. Our team offers guidance on method selection, sampling techniques, and assistance in interpreting test outcomes.