Paramount Worldwide Advisors — Regulatory framework
The ground we cover.
The alerts and code sections our work is built on. If your product falls under one of these, the path back to clearance is a documented one.
Import alerts & DWPE — all industries
- Raw agricultural commodities under pesticide alerts such as
99-05. - Processed foods, seafood, dietary supplements, cosmetics, drugs, animal feed and medical devices under alerts for salmonella, viral contamination, illegal colors, GMP failures, unapproved devices and misbranding.
- Watch-list prevention before a first detention becomes a listing.
Documentation & consulting — 21 CFR and international standards
- Food, beverages and dietary supplements —
21 CFR 101, 111, 114, 117, 123. - Drugs and APIs — CGMP, new drug approvals, misbranding, inspection refusals.
- Medical devices and quality systems —
21 CFR 820, PMA/IDE and 510(k) issues. - Cosmetics — color additive violations, microbiological contamination, adulteration and misbranding.