With over 25 years in the pharmaceutical contract laboratory industry, we add extensive experience and critical thinking to your team. We have the expertise to evaluate your API or drug product to create methods suitable for meeting today’s regulatory standards.

Method Development

We have a proven track record creating methods for testing both drug substance and drug product. Combining our experience and technical understanding, we develop methods efficiently to keep your clinical and commercial journey on schedule.

We offer traditional methodologies such as HPLC Assay, HPLC Related Substances, Dissolution (Immediate or Controlled Release), and Content Uniformity, as well as specialized development for techniques such as GC, GC-MS, or LC-MS.

Our team has ample experience with: 
• Compounds
• Potent
• Light-sensitive
• Temperature-sensitive
• DEA Scheduled II-V controlled substances
• Other challenging molecules

Dosage forms:
• Tablets
• Capsules
• Injectables
• Suspensions
• Topicals

Method Validation

Once the development is complete, our team works with you to develop a phase appropriate validation for the methodology in line with current global regulatory requirements.

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

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

Supporting your regulatory submission, our reports generated during method development and method validation are prepared to ensure you can use them directly or with minor modifications.

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