ClinAudits is an independent, 3rd party, niche provider of GXP (GCP, GMP, GLP, GTP) compliance, auditing, consulting, and training services for the pharmaceutical, medical device, biotechnology and tissue engineering industries. These services are geared toward compliance to U.S. Food and Drug Administration (FDA) guidelines, Drug Enforcement Agency (DEA) laws, International Congress on Harmonization (ICH) requirements, client and vendor SOP’s and other domestic, International and local governmental requirements. ClinAudits specializes in conducting GCP, GLP, GMP and GTP audits and providing low-cost, quality remediation solutions.
|Industry||GXP, GCP, GLP, GMP, GTP, auditing, consulting, training, compliance, quality assurance, QA, regulatory affairs, RA, pharmaceutical, biotech, medical device, and SOP|
Since 1994, ClinAudits has been an independent third party provider of GxP auditing services delivering a broad range of essential services designed to help clients meet the requirements of FDA or other governmental authorities. ClinAudits employs only GxP auditors regarded as senior level professionals with experience in complex compliance issues relating to FDA and other government regulatory authorities. On average, each member of the ClinAudits team has more than seventeen years of field auditing and consulting experience.
ClinAudits also offers services to medical academic institutions and universities around the world. These services are directed toward regulatory compliance with the U.S. Food and Drug Administration (FDA) guidelines, Drug Enforcement Agency (DEA) laws, EMA/MHRA, International Congress on Harmonization (ICH) requirements and other regulatory bodies worldwide.
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.
The company is 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.
- Good Clinical Practices
ClinAudits employs a team of subject matter expert consultants for regulatory compliance auditing projects of all sizes and scope. Our more than 57 auditors are regionally based throughout the U.S., Canada, South America, Eastern/Western Europe, China, India, Israel, Russia, Australia, Malaysia/Singapore and Japan. For all projects, our team employs quality control measures and follows appropriate SOPs to ensure that our work meets each client’s high standards.
Globally experienced, we have conducted audits in Europe (East and West), Australia, New Zealand, Russia, China, Asia, Canada, Mexico, South America (Chile, Argentina, and Brazil), Latin America, the Caribbean, India, South Africa, Israel, and the United States.
Over the past 20-plus years, ClinAudits has amassed competencies a broad range of therapeutic areas including oncology, infectious disease, respiratory disease, central nervous system (CNS), virology, cardiovascular, ophthalmology, and dermatology in Phases I through IV of clinical research.
- Good Manufacturing Practices
- Good Laboratory Practices
- Good tissues Practices
- Risk Evaluation & Mitigation Strategy (REMS)
- Quality Risk Management
- Animal Health
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