Contact our Food & Nutrition Consultants:
food@cantox.com
FOOD & NUTRITION SPECIALIZED SERVICES
SAFETY ASSESSMENT AND TOXICOLOGY SUPPORT SERVICES
The Cantox specialized team of auditors possess a detailed knowledge and understanding of Good Laboratory Practices (GLP) and have extensive Quality Assurance experience related to the design, monitoring and auditing of laboratory studies and facilities. The Quality Assurance (QA) group at CANTOX performs full-scale, third-party GLP audits at contract research organizations for its clients. In addition to being members of the internationally-recognized Society of Quality Assurance (SQA), Cantox auditors have extensive regulatory and toxicology training. This combination of scientific and regulatory expertise distinguishes Cantox auditors from traditional GLP consultants. The toxicology background of Cantox auditors enables them to understand the significance of study parameters and the importance of issues that may arise during the course of a study. Using a combination of scientific expertise and the experience gained in contract facilities, the QA group at Cantox develops GLP programs for academic and research-based facilities.
Cantox provides value-added GLP services to small biotech and large pharmaceutical companies in the following ways:
- For Sponsors Who Place GLP Studies at Contract Research Organizations (CROs):
- Conduct facility audits for pre-approval of contract lab(s)
- Conduct pre-initiation protocol reviews
- Provide access to a team of highly qualified quality assurance professionals that are experienced in all areas of GLP
- Auditors are flexible to travel worldwide for third-party QA audits on short notice
- Perform full-scale third party audits for GLP studies according to FDA (21CFR§58, including 21CFR§11), OECD Principles of Good Laboratory Practice, and Ministry of Health Labour and Welfare (Ordinance No. 21, March 26, 1997) regulatory requirements that can critically identify potential nonclinical study deficiencies in future regulatory agency audits
- Monitor and audit single studies or complete nonclinical programs
- Perform on-site GLP audits at key milestones in a study (first day of dosing, necropsy)
- Monitor and conduct audits for study progression (interim audits), and analyze nonclinical data integrity
- Perform close-out data audits prior to report finalization
- Perform third-party reviews of
draft study reports
- For Companies Wishing to Perform GLP Work In-House:
- Provide basic GLP training for groups with a preliminary interest in becoming GLP-compliant
- Perform GLP assessments to serve as a gap analysis for establishing GLP programs
- Develop customized GLP programs outlining critical steps needed to achieve compliance
- Assist in the implementation of GLP programs
- Conduct GLP “refresher” courses for laboratory personnel