Message from the President

A Message from the President of ClinAudits

Thank you for visiting our website. We appreciate your interest in ClinAudits, LLC and trust you will be able to obtain the information you seek.

Founded in 1994, ClinAudits is a global industry leader dedicated to providing GLP, GCP, GTP and GMP auditing and consulting services for the regulated, healthcare industry and life sciences communities. Targeted clients now include firms in the following industries: pharmaceutical: OTC, RX (FDA, EMEA, ICH, ISO and DEA), medical device, biotechnology/gene therapy, tissue engineering, personal care, packaging/labeling of drugs/medical devices, biological, medical institutions and universities, and GMP and GLP facilities. Our expansive list of services provides our clients with a comprehensive set of options, and has fortified ClinAudits’ position as an independent, third party provider of auditing and compliance services.

The U.S. FDA has stated repeatedly that independent auditing firms, such as ClinAudits, are the preferred choice because the potential for conflicts of interest is eliminated. ClinAudits further assures complete transparency by taking this FDA endorsement to an even higher level. Because we do not conduct or manage clinical trials (e.g., IVRS and EDC processes), ClinAudits is well positioned to emphasize our 100% objectivity and independence across a comprehensive portfolio of critical services.

ClinAudits can audit pre-clinical projects through and to commercialization and Phase IV. Our company is prepared to serve the continuing trend of firms outsourcing their auditing services. ClinAudits’ deep roster of senior level auditors and effective project management, complimented by an expert sales organization is poised to capitalize on this trend and the company stands ready to meet the demanding and ever changing needs of its clients around the world.

ClinAudits remains focused on availing high quality compliance auditing, and on delivering exceptional, customized service tailored specifically to each client’s requirements. It is upon these priorities that the company has built and continues to build its reputation. If you have questions after reviewing our website or would like to discuss a certain topic or service, please do not hesitate to contact us. It would be our pleasure to speak with you. Thank you again for your interest in ClinAudits, LLC.

Cheri Wilczek
President
ClinAudits, LLC