Pharmaceutical Quality Control
We routinely undertake microbiology and toxicology testing to GMP or GLP standards for the pharmaceutical industry, conducting pharmaceutical quality control testing and analysis of a wide variety of products for batch release into European and international markets. We offer a range of testing services for routine pharmaceutical quality control, method development and validation of products, and testing for cytotoxic and pyrogenic responses with both in vitro and in vivo methods.
We are also involved in the development of new testing methodologies with academia and pharmaceutical companies, leading the way in safety testing in the contract laboratory field. The manufacture and testing of pharmaceutical products is highly regulated to guarantee patient safety, and with over 50 years of pharmaceutical testing experience, the combined expertise of our laboratory technicians and managers enables us to be fully conversant with regulatory expectations.
Using industry standard harmonised methods compliant with Ph. Eur, USP and JP pharmacopoeial guidelines, our testing services have produced data to support regulatory applications in various global markets, including Marketing Authorisation Application (MAA) and New Drug Application (NDA) submissions in Europe and the United States. We understand our clients and the requirements and hurdles they face in getting a product to market safely, and we are happy to assist at any stage of the process.
We conduct testing on active pharmaceutical ingredients, excipients and products as well as biological preparations and fluids for a wide client base consisting of:
- Pharmaceutical manufacturers
- Discovery & biotechnology companies
- Clinical research organisations
- And other contract testing laboratories
We have extensive experience in testing regimens and products such as aerosols and inhalation devices, which can present unique challenges in removing samples aseptically. Likewise, we regularly test products which can be difficult to handle, such as cytotoxics, viscous preparations, device / pharmaceutical combinations and antibiotics. Contact us today to discuss how we can assist you in testing your products in a compliant manner.
Find out our thoughts on the future of the pharmaceutical sector, in our ‘Rapid testing methods: the cost-effective safety solution‘ article published in EPR (Issue 6, 2017). For further information regarding our pharmaceutical testing services, please follow the links in the sidebar or download an overview via PDF, here.