Chemika offers an independent chemical testing laboratory to the veterinary industry, serving both manufacturers of products containing actives under patent, and the manufacturers of generic products. These groups may have quite different testing requirements and require differing strategies.
Manufacturers of products containing actives under patent or new actives may require stability and validation data suitable for submission in a number of markets, including Europe and the USA. The chemical testing may require the development of new test methods. For new actives a cautious approach may be required, such as where new breakdown products are observed during stability trials.
The generic veterinary product market in Australia is fast moving and competitive. In providing services to generic manufacturers rapid response times and reliable test data are major considerations. Chemika has a large bank of test methods for a variety of generic actives. We are also able to work with manufacturers to develop product specifications, either prior to registration or those times when it is necessary to develop and validate them “on the run”.
Use Chemika to provide a comprehensive chemical analysis service or as a complement to in-house testing. We can fill a capability gap or provide short term relief when internal laboratories are over-loaded. We are happy to work with your technical team and can provide a valuable backup when staff changes can make it difficult to maintain continuity in the development of your knowledge base.
In addition to control testing, Chemika has considerable experience in the generation of data for submission to regulatory authorities. We can develop strategies for demonstrating in-vitro bio‑equivalence, or generate data packages for specific requirements, such as assessing broached vial stability.
Chemika has both APVMA and TGA accreditation and has become the chemical testing laboratory of first choice. We look forward to hearing from you. Please contact us now to discuss your analytical requirements.