An MHRA approved and FDA inspected facilities 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 projected manager offering a single point of contact, we can tailor our services to meet your specific quality, regulatory or scientific requirements. 

 

As a leading provider of analytical support Tepnel will be able to offer you a solution.

 

Tepnel provides analytical chemistry and quality control support for Stability Studies in accordance with the following 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 and include:

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

 

Tepnel offers a rapid turnaround time on all raw and starting materials testing, which applies to USP, EP, JP, BP and client-supplied methods. With over thirty years of 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 test 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.

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

 

Tepnel has 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 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.

Contact Us:
For further information please contact Andy Maitland, Business Development Manager,
Mobile: 07879 417942
Email: amaitland@tepnelscientific.com