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