Specialised Analytical Services
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 these pharmaceutical characterisation services to support your product submission.
We offer nitrosamine testing per regulatory requirements, with services including Risk Assessment, Testing and Mitigation. This work forms part of PharmSky’s broader pharmaceutical analytical services.
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.
Analytical Method Development and Testing
As an experienced analytical testing laboratory, PharmSky provides pharmaceutical method development, validation and GMP analytical testing to support products across different stages of development.
Our team works with clients to establish appropriate analytical approaches and generate reliable data for product development, quality assessment and regulatory submission. These capabilities can also support broader complex generic development programs, alongside PharmSky’s wider range of analytical services.
Contact Us Today
Fast track your development with our extensive services. Get in touch so we can discuss your requirements.
