R&D Technical can provide assistance with the introduction and/or modification of customer supplied and owned formulations.  Verification of raw materials, laboratory trials and scale up pilot batches are performed to ensure successful transfer of information and procedures.

Validation Services
Particularly important for customers with therapeutic goods or those required to meet stringent corporate quality guidelines, product test method and process validations can be conducted by the R&D Technical Validation Team.  Utilising the latest UPLC technology, the Validation Team can develop methods, complete method transfers or full method validations, conduct process validations and revalidations according to customer or regulatory requirements or work with Ensign to develop appropriate protocols.  The Validation Team can also provide technical advice and assistance with any validation issue.

Stability Services
R&D Technical’s Stability Team are dedicated to testing customer’s products to ensure product performance and confirm product expiry dates.  Ensign has a range of temperature and humidity controlled rooms for the storage of stability samples.  Accelerated and post-production stability testing of products can be conducted according to customer or regulatory requirements.

Regulatory Affairs
R&D Technical can provide general regulatory and compliance advice, review artwork for regulatory compliance, and list or register products with the APVMA, TGA or other Australian or international regulatory authorities