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Method Development & Validation

Metrics Contract Services has a dedicated group of experienced chemists providing method development and method validation services.

Our scientists display the critical thinking and have the appropriate expertise to evaluate your active pharmaceutical ingredient or drug product to allow for the creation of methods suitable for meeting today’s regulatory standards. With over 20 years in the pharmaceutical contract laboratory industry, Metrics’ scientists have helped our customers overcome some of the most difficult development efforts.

Method Development

With a proven track record of technical success, Metrics has the ability to create methods for testing of both drug substance and drug product. Experience includes traditional methodologies such as HPLC Assay, HPLC Related Substances, Dissolution (Immediate or Controlled Release), and Content Uniformity. This group is also responsible for specialized development for techniques such as GC, GC-MS, or LC-MS.

The development team has experience with a wide range of unique and specialized compounds:

  • Potent
  • Light-sensitive
  • Temperature-sensitive
  • DEA Scheduled II-V controlled substances
  • Other challenging molecules

As well as the following dosage forms:

  • Tablets
  • Capsules
  • Injectables
  • Suspensions
  • Transdermals

Method Validation

Once the development is complete, the validation group will work with our clients to develop a phase appropriate validation for the methodology. This approach is in line with current FDA guidelines and feedback we get from our clients.

Depending on the method, our scientist will challenge the method on:

  • Accuracy
  • Precision
  • Linearity
  • Stability
  • Specificity of Solution
  • Robustness

Reports generated during both method development and method validation are prepared in such a way that our clients can use them directly or with slight modification for regulatory submission documentation.