People. Progressive. Principled

cGMP Analytical Services

Supporting Drug Development

Our people and our range of services provide outsourcing partners an opportunity to obtain regulatory compliant data that supports your CTD or gets your product out into the marketplace.

Tepnel Pharma Services specialises in the provision of pharmaceutical testing in support of drug development. Our cGMP pharmaceutical testing facilities are located in Livingston, Scotland where we are committed to providing laboratories with the most innovative and effective technologies from sample receipt through to report delivery. With over 30 years’ CRO experience of pharmaceutical testing, we provide regulatory compliant analytics in support of small and large molecule APIs, IMPs and finished products. Our people are committed to continuous improvement and development of our processes to create value propositions on behalf of our clients. Under inspection and approval of the MHRA and FDA, our pharmaceutical testing services include:

Lot and batch release testing

Regulatory compliant batch release testing & QC testing of pharmaceuticals and biopharmaceuticals for release in the European and Global Markets. Our rapid and flexible service ensures a quick turnaround that shortens the period from product manufacture to availability to the patient.

ICH stability testing and storage – small molecule and biopharmaceutical

Our on-site analytical chemistry and microbiological support together with a range of validated cabinets and chambers ensure that your ICH stability testing projects are carried out efficiently and in compliance with ICH Q1 guidelines.

Pharmacopeial and raw materials testing

We provide comprehensive raw material testing, pharmacopeial testing and microbiology testing of excipients and ingredients.

ICH method development and validation

Services include analytical method development & validation in accordance with the ICH Q2 (R1) guidance and cGMP for both small and large molecules.

Sections in cGMP Analytical Services

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