Our team provides quality service with rapid turnaround at a competitive cost. You can rely on strong scientific expertise at our Bioanalytical Laboratory in Austin, Texas. From discovery to post-marketing, we partner with your team to develop a custom method, transfer/optimize and validate an existing method, identify liabilities and de-risk a regulated assay, or adapt a method to increase efficiency and cost-effectiveness.

Our scientists routinely analyze more than 30,000 samples per month and have demonstrated capability up to 45,000 samples per month.

With state-of-the-art bioanalytical instrumentation and more than 2,000 validated assays, we are at the forefront of the industry in the development of bioanalytical methodology.

Our bioanalytical work meets all regulatory standards, including:

  • FDA Regulations (US Code of Federal Regulations, 21 CFR) for, Good Laboratory Practice, Good Clinical Practice (GCP), Bioavailability and Bioequivalence Requirements, conduct of clinical trials, and human subject protection.
  • European Clinical Trials Directive 2001/20/EC and Commission Directive 2005/28/EC.
  • UK Medicines and Healthcare Products Regulatory Agency (MHRA) requirements.

Our quality assurance and control processes add another level of methodology and oversight. We appreciate the opportunity to demonstrate excellence.

Specimen Control

We ensure that every biological sample is properly collected and handled to avoid pre-analytical errors. Upon receipt of samples —

  • Containers are opened to ensure all samples are frozen and intact.
  • Samples are logged into our Watson Laboratory Information Management System (LIMS) database and given a unique identification number to track them through all stages of preparation and analysis.
  • The temperature of each -20C or -70C freezer is monitored by both Tyco Integrated Security as well as a Vaisala data logger.