An MHRA approved and FDA inspected analytical chemistry facility working under a GXP quality system, we have a stable and dedicated workforce ensuring continuity of service from start to end of any project. With dedicated project managers offering a single point of contact, we can tailor our analytical chemistry services to meet your specific quality, regulatory or scientific requirements. 

 

Analytical Chemistry Services include:

 

We provide ICH stability testing in support of Stability Studies in accordance with International Conference on Harmonisation (ICH) guidance documents under current Good Manufacturing Practices. With over 40m2 of stability storage, in which all our conditions are mapped, qualified and validated traceable to national standards, out stability testing services include:

With our on-site microbiological support and 24hr monitoring and emergency call out facility on-site, we manage your projects effectively and efficiently.

 

We offer a rapid turnaround time on all raw materials testing, which applies to USP, EP, JP, BP and client-supplied methods. With over thirty years of raw materials testing experience, we have encountered most, if not all, available product types in our laboratory. We have a wealth of practical knowledge, experience and adaptability, which we believe is second to none. All of our raw materials testing documentation is detailed and regulatory compliant to cGMP at test completion and because of the stringent checks and balances between the laboratory and Quality Assurance.

We provide analytical chemistry and quality control support for Method Development and Validation in accordance with ICH guidance documents under current Good Manufacturing Practices. We have extensive method development and validation experience combined with dedicated resources providing a value added service for a large variety of techniques, materials and product types.   We can provide full method development and validation, re-validation and analytical method transfer exercises

 

We have been confirmed as operating in accordance with the principles of Good Manufacturing Practice 3, as a contract acceptor on authorisations issued by the MHRA and the FDA. Our experienced analytical chemistry capabilities coupled with our Qualified Person Permanent Provisions allows us to satisfy the requirements of the Clinical Trials Directive and certify both IMPs manufactured and imported from within and outside the European Union/European Economic Area.

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Gen-Probe Life Sciences Ltd.