The mission of the Bioanalytical department of Primera Analytical Solution Corp (PASC) is to provide all necessary bioanalytical supports to facilitate clients’ drug discovery, drug development, NDA/ANDA applications and drug approval process.

 

Discovery Support

LC-MS/MS Method Development, Qualification, & Sample Analysis

  • Fast method development with experienced analysts (typically 1 to 3 days)
  • Competitive pricing without compromising on quality
  • Experience in handling very complicated biological matrices such as animal tissues, skin, and bones, etc.
  • Quick turnaround for results delivery (1 to 2 weeks including both method development and sample analysis)

 

LC-MS/MS Method Development & Validation (GLP)

  • Fast turnaround for method development
  • Competitive pricing without compromising the quality
  • Full method validation in various kinds of biological matrices/tissues
  • Fully compliant with GLP regulation

 

Complex Method Development and Validation package including:

 

  • Accuracy & Precision
  • Linearity
  • Specificity & Selectivity
  • Limit of Quantitation (LOQ)
  • Matrix effect evaluation

 

 

  • Extraction recovery
  • Analyte Stability in Matrices
  • Stock/Spiking Solution Stability
  • Ruggedness

Partial and/or cross-validation for existing methods

Bioanalytical support for preclinical and clinical studies including both small and large molecule drugs