Clin Audits - Building Trust in Clinical Research, GXP Auditing and Consulting Since 1994

Clinical Research at ClinAudits

Nationality

American

Current location

United States

Work category

Medical and Nursing

While headquartered in Kinnelon, New Jersey, ClinAudits LLC sends compliance professionals around the world. To date, the company has assisted more than 400 life sciences organizations by deploying the nearly 600 years of cumulative experience held by ClinAudits’ senior auditors. The firm expertly guides clients through the compliance regulations established by the United States, local governments, and international organizations, such as the International Congress on Harmonization (ICH), the European Medicines Agency (EMEA), and other regulatory authorities. Many different clients have benefited from ClinAudits’ knowledge of good practice (GXP) guidelines and regulations. Aware of the multitude of issues inherent in creating new drugs and biologics, performing gene therapy, and designing active pharmaceutical ingredients, the regulatory compliance professionals interact with clients during every step of the development process.

Clin Audits's Professional Experience

1994 - Present

ClinAudits - Clinical Research

ClinAudits’ services concentrate on evaluating Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), Good Tissue Practices (GTP), and Good Laboratory Practices (GLP), while ensuring compliance with additional internal policies and procedures. Potential clients can also hire this third-party consultancy for medical writing assignments, assistance with a U.S. Food and Drug Administration (FDA)-mandated Risk Evaluation and Mitigation Strategy (REMS), and the development of training programs for various types of personnel. In 2009, Congress gave FDA expanded power over the tobacco industry with passage of the Smoking Prevention and Tobacco Control Act. ClinAudits understands the relatively new law and offers the firm’s expertise to tobacco manufacturers and retailers. Some notable elements of the statute include laws related to the selling and advertising of tobacco products to youth, and the prohibition of offering tobacco in conjunction with another product which is a violation of the Federal Food, Drug, and Cosmetic Act. By engaging ClinAudits’ services, tobacco companies can follow the myriad rules and regulations developed by the federal government pertaining to labeling, advertising, product descriptors, and smokeless tobacco, as well as receive guidance on policy issues.

Clin Audits's Additional Information

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