ClinAudits, LLC Email Format

Pharmaceutical ManufacturingNew Jersey, United States2-10 Employees

ClinAudits, LLC is a niche, independent provider of GXP compliance services, including auditing, consulting, and training for the pharmaceutical, medical device, biotechnology, and tissue engineering sectors. The firm focuses on ensuring adherence to U.S. FDA guidelines, DEA regulations, ICH requirements, and other applicable domestic and international standards, with an emphasis on conducting GCP, GLP, GMP, and GTP audits and offering remediation solutions that aim to be cost-effective. Based in Kinnelon, New Jersey, the company operates as a small, specialized outfit serving organizations navigating complex regulatory landscapes and seeking third-party assurance of their compliance programs. ClinAudits positions itself within the pharmaceutical manufacturing and related industries as a focused, third-party resource for audit and compliance needs. A notable milestone in its history is recognition as a National Women’s Business Enterprise by the WBENC, indicating certification status relevant to its market identity.

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