Quality and Regulatory

Compliance: A Component of Quality

Toxikon’s vast experience in conducting safety and efficacy studies is performed with best practices in accordance with domestic and international regulatory agencies.

Toxikon’s staff includes highly experienced quality assurance and regulatory professionals with RAC and RQAP-GLP certifications. Toxikon’s international GxP programs are operated under its broader ISO 17025 quality systems, and all data automation processes are fully validated, including electronic/ digital signatures wherever possible.

Our FDA-registered and ISO 17025-accredited facilities in Bedford and Leuven, Belgium, are routinely inspected by these and other regulatory and international agencies, with positive outcomes that are available upon request from our clients. Toxikon is experienced in protocol preparation for IACUC and IRB submissions.

Our facilities meet all of the requirements of the federal and state laws pertaining to laboratory models under the AWA as enforced by the USDA, and our protocols and approval process are reviewed routinely by USDA, FDA, and equivalent European and Japanese regulatory agencies. Our facilities are also accredited by the Association for the Assessment and Accreditation of Laboratory and Animal Care (AAALAC).