Unparalleled Staff Expertise Promotes Quality in all We Do
Toxikon conducts safety and efficacy studies in accordance with industry best practices as well as domestic and international regulatory agencies. Our dedicated quality assurance unit closely monitors all aspects of our studies, from design and execution through delivery of results. Sponsors can have confidence that their test results provide precise, accurate, and actionable data to help shepherd their products to market.
For over 40 years, Toxikon has served the pharmaceutical, medical device, and biotechnology industries. The value we deliver to you comes from the capabilities of our staff — our scientists, technicians, and quality assurance professionals who have the experience, training, and credentials to deliver high-quality service. Key members of Toxikon’s quality and regulatory staff include professionals with RAC and RQAP-GLP certifications.
Independent Accreditations Confirm our Total Commitment to Quality Management
Toxikon is governed by a robust quality management system, ensuring compliance with Good Documentation Practices, Good Laboratory Practices, and other industry-specific best practices. We follow processes to deliver the same high-quality results each and every time. Our GxP programs are executed under our comprehensive and rigorous ISO 17025-governed quality system, and all data automation processes are fully validated, including electronic/ digital signatures wherever possible.
Best-in-Class Facilities and Methods Support Quality Execution of Medical Product Testing
Our USDA- and FDA-registered facilities are routinely inspected by these and other regulatory and international agencies, with positive outcomes that are available upon request from our sponsors. 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).