People. Progressive. Principled

QbD Method Development and Validation

The team at Tepnel Pharma performs analytical method development and validation in accordance with the ICH Q2 (R1) guidance and cGMP for both small and large molecules.

Our established method development and validation service offers the development and validation of regulatory compliant procedures ranging from conventional HPLC through to complex monoclonal and polyclonal bioassays that can be routinely used to support either stability testing or lot release testing in the discovery, development and manufacture of pharmaceuticals. You can read more on our Method Development and Validation services here.

We have now invested in Fusion QbD software which in conjunction with Waters® Empower™ and H-Class UPLC Systems provides an integrated solution for robust method development and optimisation, reducing turnaround times from start to finish by ca 30-50% depending on the analytical complexity required.

This approach can be used to design and develop an analytical test method approach using QbD strategy which results in a high quality robust and consistent method ready for validation very quickly when compared to a more traditional approach. Read more on Fusion QbD here.

Offer! Save time and cut costs with Tepnel

Sign up today for an HPLC MD&V potency and/or purity programme at Tepnel and benefit from a cost saving of 15% as a result of our new Fusion QbD software.

Additionally, place your follow on analytical programmes that use validated methodology such as ICH stability testing or batch release testing with Tepnel, and you will receive a further 10% discount of all future studies that use our methods.

Contact the team today:

Call: +44 (0)1506 424 270 or Email: 

Meet us at Making Pharma!

Tepnel Pharma Services are exhibiting at  both Making Pharmaceuticals Europe (13th-14th March 2018) and Making Pharmaceuticals UK (24th-25th April 2018). For full details visit our events page, or to arrange a meeting with one of the team contact Liz Symington or Alex McDowall today.



Contact us today to find out how much you can save with Tepnel

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