Chemika offers comprehensive chemical testing to pharmaceutical manufacturers and researchers, from raw materials to finished products, stability testing, method development and validation and manufacturing support.
Chemika is the only contract testing laboratory in Australia focussing focus exclusively on the chemical testing of therapeutic goods and devices. This specialisation has allowed us to develop expertise in many aspects of chemical testing in pharmaceutical manufacturing. Our core expertise is raw material and finished product testing, with services extending to support manufacturing. This includes cleaning validation studies, stability testing (real time, accelerated and in-use), photostability testing, and mixing validation.
Chemika has a history of providing support for manufacturing and product development, both in the development and implementation of protocols, and in this way we can be regarded as a contract research organisation. Our broad expertise is of great benefit to researchers where a new active is being developed for clinical trials, where the idea is being taken from a promising active which is being prepared to administration in clinical trials. Chemika is able to generate initial dose stability data and put drug developers on the path to develop methods, product specifications and data dossiers for registration, putting the product on a solid path to market.
We are proficient in testing a large number of sample types using a wide variety of techniques for methods which appear in the BP, USP, and Ph.Eur. Methods include traditional wet chemical techniques as well as specialised instrumental methods.
As a GMP licensed laboratory our results can be used for the release of pharmaceutical products for sale or for regulatory submissions. Thorough validation and verification procedures for methods and instrumentation means that results are consistency of a high quality and can be used with confidence.
We are equipped with walk in stability chambers and cabinets which allow for stability data to be acquired for a variety of conditions. We are proficient at developing and implementing protocols to deliver high quality data which speaks for itself.
We are experienced in developing methods to allow for analysis of products and materials using a wide variety of analytical techniques, and proceeding to validation according to protocols meeting the requirements of Australian and international regulators.
Measuring drug residue concentrations requires a customised approach to method development and validation. Our expertise has benefitted numerous manufactures resulting in regulatory compliance and peace of mind.