GxP Audits and Consulting
ClinAudits GxP pharmaceutical auditing expertise can now assist clients in tobacco clinical, manufacturing and laboratory auditing and retail training. We serve as a single resource for guidance on regulatory and policy issues related to tobacco products.
As a highly specialized, independent third party niche provider for GxP services, ClinAudits focuses its efforts on meeting end-to-end FDA compliance requirements as outlined in the 2009 Smoking Prevention and Tobacco Control Act.
ClinAudits is a global, independent and impartial organization with unmatched auditing credentials. We operate strictly within the regulations/guidelines set forth by the FDA and other government authorities to regulate the manufacture, marketing and distribution of tobacco products, while protecting public wellbeing as it relates to known tobacco-related health risks and to reducing tobacco use by minors.
Compliance and regulatory services include (but are not limited to):
- Tobacco Retailer Training Programs
- Tobacco Health Document Submission
- Regulation Compliance Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents
- The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act
- Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco
- “Harmful and Potentially Harmful Constituents” in Tobacco Products
- Use of “Light”, “Mild”, “Low”, or Similar Descriptors in the Label, Labeling, or Advertising of Tobacco Products
- Enforcement Policy Concerning Rotational Warning Plans for Smokeless Tobacco Products
- Registration and Product Listing for Owners and Operators of Domestic Tobacco Product Establishments
- Listing of Ingredients in Tobacco Products
- Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act
- Timeframe for Submission of Tobacco Health Documents