Providing professional auditing and consulting services for the life sciences since 1994, ClinAudits, LLC, ensures the strictest compliance with the guidelines from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMEA), and other regulatory authorities. The experts at ClinAudits specialize in Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and Good Tissue Practices (GTP), as well as in navigating the Risk Evaluation and Mitigation Strategy (REMS). Since the FDA Amendments Act of 2007 (FDAAA), the FDA requires every drug and biomedical product to have an REMS associated it.
With specialists in the U.S., Canada, and Europe, ClinAudits offers domestic and international auditing in North and South America, Europe, Mexico, Russia, Australia/New Zealand, Asia, and South Africa. Many companies in medical device design and manufacturing, pharmaceutical, tissue manufacturing, and biotechnology industries fail to understand the nuances associated with regulations and the basic tenets of good operating procedure. Hiring an experienced auditor from ClinAudits provides a company with the assurance of transparency, traceability, and accountability. Auditors at ClinAudits boast an average of more than 17 years’ experience and approach their work with corporate, cultural, and political sensitivity.
A proud member of the Bioanalytical Quality Standard Initiative (BQSI) Expert Working Group since 2010, ClinAudits believes investing in the auditing and consulting community is essential to maintaining high industry standards. “As a provider of objective compliance audits and quality remediation solutions, ClinAudits is aware of the inconsistencies in the conduct of bioanalysis in support of current clinical trials,” said ClinAudits’ founder Cheri A. Wilczek. ClinAudits offers its services to reverse the current trend of inconsistencies and failed audits for any organization. Furthermore, ClinAudits supports its clients by providing additional services in regulatory affairs, project management, monitoring, and medical writing.
