Regulatory Testing & Compliance
In the pharmaceutical industry, quality is paramount. At QualTech Laboratories, we ensure the highest degree of quality for your biological assays, heparin studies, anti-factor Xa activity testing, anti-factor IIa assays, and toxicity studies through:
- FDA and USDA registration. All FDA and USDA regulations including sanitation, cleanliness, animal care, training, and traceability are strictly complied with. We welcome your auditing team to tour our facilities, speak with our staff, and examine our Establishment Inspection Report (EIR).
- GMP compliance. We comply with all applicable Good Manufacturing Practices so that your company and your product are above reproach. This includes detailed batch records, ongoing personnel training, complete assay documentation, and cradle-to-grave traceability.
- USP, EP, and BP test methods. We have validated methods and supporting tests for USP (United States Pharmacopeia), EP (European Pharmacopoeia), and BP (British Pharmacopoeia) methods, so your drug can proceed to market anywhere in the world. Additionally, if you need a customized protocol in conjunction with one of these standardized methodologies, we would be glad to work with you to develop a valid assay.