C.HUMPHREY & ASSOCIATES P.A.

Humphrey Regulatory Consulting, LLC is a leading provider of the US FDA Regulatory Compliance services in the United States. Compliance with US FDA regulations is important for companies to expand to the global market. However, the FDA can also cause serious financial consequences as well as irrevocable damages on the corporate image if not complied within a timely manner. Particularly the last year's imports alone, the FDA had refused more than 15,500 products from abroad, and this strict screening process is expected to continue under the current Administration.

Our compliance consulting services offer one of the most extensive networks of FDA experts. Our consultants have more than 20 years of experience in their specialty field, related to approval, compliance and import process of FDA-regulated products. Our regulatory consulting group is comprised of delivers effective results for our clients through a combination of experience and creative problem solving strategies. We handle a full array of FDA, Customs, USDA, and related regulatory agency matters. Our expertise extends to foods, medical devices, pharmaceuticals, OTC drugs, biologics, biotechnology, animal feeds and drugs, cosmetics, and electronic radiation products, animal drugs and consumer products.

We assist our clients in responding to FDA 483s, warning letters, injunctions, prosecutions, detentions, refusal, Customs penalties and import alerts. Our expertise on promotion and advertising, labeling issues, exports and imports, MDR reporting, QSR and GMP requirements, and other regulatory issues provides our clients with confidence and security that their products and processes are compliant in the most cost-effective manner available. We also prepare our clients for meetings with FDA personnel on compliance matters and represent clients before the Agency on enforcement, policy and rulemaking issues, and litigation.