REGULATORY COMPLIANCE

Regulatory Compliance

XenoTech’s Quality Assurance Unit (QAU) and Quality Control Unit (QCU) are committed to ensuring that industry and government standards are met or exceeded within our organization. Studies conducted and products manufactured by XenoTech are protocol-driven and carried out in accordance with facility Standard Operating Procedures (SOPs) and applicable regulatory agency guidelines including:

• US FDA Good Laboratory Practice for Nonclinical Laboratory Studies
  21 CFR Part 58
• US EPA Federal Insecticide, Fungicide, and Rodenti­cide Act (FIFRA): Good Laboratory Practice Standards 40 CFR Part 160
• US EPA Toxic Substances Control Act (TSCA): Good Laboratory Practice Standards 40 CFR Part 792
• Organisation for Economic Co-operation and Development (OECD) Principles on Good Laboratory Practice
• Japan Ministry of Health, Labour and Welfare (MHLW) Good Laboratory Practice Standards Ordinance No. 21

The collective goal of the QAU and QCU is to ensure that all of the applicable laboratory and facility functions leading up to final products and services are carried out under stringent and regulatory-compliant conditions. The end results are high quality, with good record-keeping and sound, defensible and reproducible data. To aid in meeting this goal, the QAU and QCU maintain a strong presence within the company, which is manifested through periodic, in-process monitoring, routine data audits, report reviews and regular facility inspections.

We welcome visits from our study sponsors and potential customers. To schedule a visit, please contact us.