Method Development

Method Development
Our Laboratory can provide method development and method validation protocols to support ANDA, NDA, and INDs in compliance with current FDA and ICH Guidances.

Method Development Services:

  • Identification
  • Assay testing
  • Impurity determination
  • Stability indicating methods
  • Moisture
  • pH
  • Total Organic Carbon
  • Oxidative and reductive stress
  • Light stressing
  • Microbial testing

Method Validation Services:

  • Accuracy
  • Precision Repeatability
  • Intermediate precision
  • Reproducibility
  • Specificity
  • Detection limit
  • Quantitation limit
  • Linearity
  • Range
  • Robustness
  • System Suitability Testing

 

Formulations

Formulations
Our Technical Services Team has developed an array of OTC and Vaping Products for Private Label production under your brand or they can evaluate your formulations to improve efficacy, reduce cost, or insure stability. And they are vastly experienced at preparing the work instructions for either test or commercial production.