ClinAudits assists clients in the pharmaceutical, biotechnology, biologics, gene therapy, tissue engineering, and medical device industries to meet FDA and other regulatory agencies compliance requirements, both domestically and internationally. We are a highly specialized, independent, third party provider of Good Clinical Practices (GCP), Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), PV (pharmacovigilance/drug safety), Good Distribution Practices (GDP), REMS (Risk Evaluation and Migitation Strategy) and Good Tissue Practices (GTP) auditing and consulting. Quality assurance auditing, specifically in clinical and laboratory practices and critical path manufacturing processes, is essential to achieving 100% compliance during development from Preclinical to Phase IV through commercialization. The ClinAudits team of subject matter experts provides best practices to help you confidently and effectively accomplish your objectives. As a global, independent and unbiased third party consultant, ClinAudits has unsurpassed auditing credentials. ClinAudits operates within the regulations and guidelines set forth by the FDA and other governmental authorities whose role is to ensure that products authorized for marketing have been produced to exacting standards in terms of manufacturing and production, field-proven efficacy and patient safety. ClinAudits has been awarded a Women-Owned Business Enterprise certification.
Offices in :
170 Kinnelon Road, Suite 17 Kinnelon, NJ 07405