At QualTech Laboratories, we will partner with you to achieve FDA approval and maintain ongoing quality control of your hormone medications or heparin drugs through:

  • Biological assays that ensure your drug’s quality and integrity.

  • Animal studies that comply with USP, EP, or BP methods and all supporting tests for those monographs.

  • Toxicity testing to check for contaminants and toxins.

  • Stability testing at prescribed time intervals, temperatures, and humidity levels.

  • Quality testing for each new release batch of your drug.

  • Method validation that typically includes accuracy, precision, specificity, detection limits, quantitation limit, linearity, range, and robustness studies.

  • Protocol preparation to help you comply with the regulatory requirements for method development and validation.

  • Customized testing to meet your company and drug’s unique requirements. 

QualTech – Your #1 Analytical Testing Laboratory in the U.S. Specializing in:
Biological Assays · Heparin Studies · Toxicity Studies
Anti-Factor Xa Activity Testing · Anti-Factor IIa Assays

QualTech Laboratories, Inc.  |  104 Green Grove Road, Ocean, NJ 07712  |  Phone: 732-918-0207 Design by Ginger Graphics