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cGMP Analytical Services Supporting drug development, improving patient outcomes

cGMP Analytical Services€¦ · Tepnel Pharma Services Limited, Appleton Place, Appleton Parkway, Livingston, West Lothian, EH54 7EZ, UK | T: +44 (0)1506 424270 | F: +44 (0)1506

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Page 1: cGMP Analytical Services€¦ · Tepnel Pharma Services Limited, Appleton Place, Appleton Parkway, Livingston, West Lothian, EH54 7EZ, UK | T: +44 (0)1506 424270 | F: +44 (0)1506

cGMP Analytical ServicesSupporting drug development, improving patient outcomes

Page 2: cGMP Analytical Services€¦ · Tepnel Pharma Services Limited, Appleton Place, Appleton Parkway, Livingston, West Lothian, EH54 7EZ, UK | T: +44 (0)1506 424270 | F: +44 (0)1506

Overview of Services

Lot and Batch Release TestingRegulatory 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.

Pharmacopoeia and Raw Materials TestingTepnel offers a comprehensive raw material testing, pharmacopoeial testing and microbiology testing of pharmaceutical excipients and ingredients service to meet a wide range of different purposes.

ICH Stability Testing and StorageOur 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.

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

People. Progressive. Principled.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.

cGMP Analytical ServicesTepnel 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.improvement and development of our processes to create value propositions on behalf of our clients.

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.

Page 3: cGMP Analytical Services€¦ · Tepnel Pharma Services Limited, Appleton Place, Appleton Parkway, Livingston, West Lothian, EH54 7EZ, UK | T: +44 (0)1506 424270 | F: +44 (0)1506

Life Sciences ScotlandScottish Life Sciences

Tepnel Pharma Services is proud to be a part of the Scottish Life Sciences community. Together, this community has developed a vision that by 2020 Scotland will have:

The Life Sciences Scotland identity exists to unify the community and to broadcast Scotland’s depth of expertise in life sciences across the world.

A globally focused, sustainable life sciences sector built on a fully connected national strategy that exploits strengths in scientific excellence, financial services and innovative business models, and that develops, retains and builds upon Scotland’s talents.

tepnelpharmaservices.com | [email protected] ©2020 Tepnel Pharma Services Limited. All rights reserved. Tepnel Pharma Services Limited (“Tepnel”), Nucleon Extraction Kits (“Nucleon”) and all associated logos are trademarks and/or registered trademarks of Tepnel. This information is intended for users of the Tepnel website, Life-Science professionals and is not intended as a service or product solicitation or promotion where such activities are prohibited. Views and opinions expressed herein by third parties are theirs alone and do not necessarily reflect those of Tepnel. Because Tepnel materials are distributed through websites, e-channels, hard-copy documents and tradeshows, it is not always possible to control where such materials appear. For specific information on what services or products are available for sale in a particular country, please contact Tepnel at [email protected]

Tepnel Pharma Services Limited, Appleton Place, Appleton Parkway, Livingston, West Lothian, EH54 7EZ, UK | T: +44 (0)1506 424270 | F: +44 (0)1506 424280 tepnelpharmaservices.com | Registered in Scotland No. SC635641

cGMP Analytical ServicesSupporting Drug Development, Improving Patient Outcomes

As part of a leading global healthcare and diagnostics company, our people strive to provide quality control laboratory analysis which helps advance the realisation of precision medicine and a value healthcare system which improves patient outcomes.

We believe that it is our responsibility to provide our customers with high quality, regulatory compliant data. Customers gain access to our knowledge, experience and ability to help them simplify their studies which facilitates diagnostic solutions that can work to achieve both incremental and transformational progress towards improving patients’ lives.

We are successful because of our People. We are Progressive in our way of thinking. We believe in our Principles.