Bioanalytical Expertise

O
ur highly experienced and dedicated team of bioanalytical scientists has developed numerous assays in support of several hundred studies. Alliance Pharma’s bioanalytical expertise in delivering timely and dependable results to clients has earned us an excellent reputation in dealing with troubled assays and challenging bioanalytical methods.

 

Alliance Pharma’s bioanalytical team has extensive experience in developing and validating robust LC-MS/MS methods for a wide variety of compounds in various biological matrices (including blood, urine and tissue specimens) to support all phases of pre-clinical and clinical studies.
We maintain a high standard of excellence and deliver accurate assay results in a timely and cost-effective manner.

Bioanalytical Services

The bioanalytical team offers method development, assay validation and specimen analysis using state-of-the-art liquid chromatography and mass spectrometry (LC-MS/MS). We conduct method validation and sample analysis in compliance with regulatory guidelines to support all stages of pharmaceutical development. Methods are developed and validated in accordance with either client-specific protocols or internal SOPs and all methods are validated to meet MHRA, FDA and/or ICH guidelines. We are capable of handling both controlled substances (schedule 2 to 5) and radioactive materials. A list of our current offerings is as follows:

  • Method transfer and optimization
  • Method development and validation
  • Support for pre-clinical TK/PK studies
  • Analytical support for clinical trials
    • Pharmacokinetic (PK) studies
    • Bioequivalence studies
  • High throughput analysis to support discovery TK/PK/PD studies

 

Technology Platforms

  • HPLC-UV/Visible
  • LC-MS and LC-MS/MS (Sciex API 4000, 5500, and 6500; Thermo Scientific Q Exactive)

Available Assays

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