Method Development and Validation

Analytical method development and validation are critical components of any pharmaceutical development program.  Expertise in pharmaceutical method development and validation is important.  Method development and validation help ensure your process and product purity profiles meet acceptance criteria, and are also an integral part of final submission.  Lucideon’s experts have extensive industry experience and are supported by the latest state-of-the-art analytical instrumentation.

Our experienced scientists can develop new methods for your products. These can be developed and validated to ICH guidelines which include the following parameters:

  • linearity
  • limit of detection (LOD)
  • limit of quantification (LOQ)
  • specificity (including stability of solutions)
  • precision (method, intermediate and system)
  • accuracy (recoveries)
  • robustness
  • forced degradation.

Method development

Whatever your product, material or process Lucideon has the expertise to help.  Our team of experienced analytical chemists can develop methods to tackle specific problems encountered during the development phase, or to aid safety evaluation of a pharmaceutical product.  We can help you to assess any risks related to impurities, whether related to packaging (Extractables and Leachables), raw materials or manufacturing processes.  We can also provide support for cleaning validations of production lines, amongst many other offerings.

Method validation

Lucideon acts as your partner throughout and beyond your pharmaceutical method validations.  We work to understand your requirements in the context of your overall procedures and end goals, to provide a personalized offer specific to you.  A long term partnership with us means that revisions and future method validations will be quick and easy, making the process even more efficient for you.

Our pharmaceutical method validation service will ensure that your analytical processes are suitable for application in your drug development program.  Method development can help to improve the whole drug production process, but it is also important that your methods are fully validated to support regulatory submission of your products.

Our advanced instrumentation and expert knowledge helps to minimize time and costs involved in achieving detailed and reliable data. We perform trace level analysis and our approaches are suitable to identify physical and chemical properties of matrix and dosage forms.

Our method development and validation services cover each stage of product development and can be done from scratch or used to strengthen existing procedures. We also offer validation of existing procedures.

We specialize in understanding your requirements and delivering high quality results so please get in touch and one of our experts will respond as soon as possible.

Webinar Recordings:

» Perspectives on Extractables - Pharmaceutical Products and Medical Devices
» Update on USP Tests for Elemental Impurities - Are you ready?

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