Auditing
Audits are an integral part of a company’s compliance responsibilities. However, for many companies, finding the time and personnel to conduct these audits is a challenge. Jeiven can assist with all of your auditing needs. For more than 30 years we have conducted audits globally on behalf of our clients. Our highly experienced auditors conduct independent evaluations and can assist with remediation of any problems found.
Our audits are conducted in coordination with your team members to make sure that the audit meets your company’s specific needs. We do not take a cookie-cutter approach; we will work with your organization to create a customized audit agenda and to conduct a thorough, independent audit.
Jeiven conducts GMP, GCP, GLP, GDP, QSR, Data Integrity, IRT, Pre-Approval Inspections, Venture Capital Due Diligence, and Mock Regulatory audits globally. We also conduct DEA audits throughout the US. We have auditors on the ground in the US, Canada, Europe, India, China, and South America.
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Data Integrity Audits
Data Integrity refers to maintaining and assuring the accuracy and consistency of data over its entire product life-cycle.
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DEA Audits
The DEA (Drug Enforcement Administration) oversees all places of business that handle controlled drug substances.
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Dietary Supplements Audits
The FDA regulates both finished dietary supplement products and dietary ingredients. In addition, dietary supplements and dietary ingredients are subject to the Food Safety Modernization Act (FSMA). Audits are required to ensure that your products are manufactured and distributed in compliance with the applicable regulations.
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GCP Audits
GCP (Good Clinical Practice) audits are required for companies conducting clinical trials on investigational medicinal products or medical devices that involve the participation of human subjects.
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GDP Audits
European guidelines require that all stakeholders in the supply chain of medicinal products comply with Good Distribution Practices. Sponsor companies of medicinal products must ensure that their products will be distributed under controlled conditions.
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GLP Audits
GLP (Good Laboratory Practice) Compliance audits are required for non-clinical laboratory facilities conducting safety and toxicology testing in animals including the toxicology facilities and bioanalytical laboratories.
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GMP Audits
GMP (Good Manufacturing Practice) audits help ensure that products are manufactured via the Quality standards stipulated by the FDA and other health authorities
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Interactive Response Technology Audits
IRT audits can be some of the most confusing audits our clients have to deal with. IRT vendors are responsible for the data obtained during a clinical trial. If there is a problem with your IRT vendor, your entire trial can be in jeopardy.
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Medical Devices Audits
Manufacturers, specification developers, contract manufacturers, re-labelers/re-processors, and even some distributors must implement a quality management system compliant with the QSR.
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Venture Capital Due Diligence Audits
Jeiven works with venture capital firms and attorneys to help assess the investment potential of healthcare companies and contract research organizations of all sizes.