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.