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sharon
@sharon7709
Trusted FDA Registration and US Food Import Compliance Expert
Nigeria
Englisch, Spanisch, Deutsch
Über mich
Hi! I’m your dedicated FDA consultant, passionate about helping brands navigate the complex world of US regulatory requirements. With deep expertise in FDA registration, FDA listing, and FDA compliance, I simplify the path for food, cosmetic, medical device, and supplement businesses. Whether you need a US FDA Agent, MOCRA cosmetic registration, or a Food Facility expert, I provide the detail-focused regulatory consulting you need. Let’s ensure your FDA application is flawless so you can enter the U.S. market with total confidence!
Kompetenzen
sharon
offline •
Durchschnittliche Antwortzeit: 1 Stunde
Meine Dienstleistungen
Rechtsrecherche
I will fda registration, fda listing, fda compliance, USA food import permit assistance
Gewerbeanmeldung
I will handle fda facility registration, food, drug, cosmetic and US import permit
Arbeitserfahrung
Junior Registration Coordinator
Global Marketing Services • Freiberufler
Jan 2023 - Present • 3 yrs 4 mos
Since establishing my independent consultancy, I have become a pivotal partner for global brands seeking to navigate the intricacies of the U.S. market. My primary focus is providing end-to-end FDA registration and FDA compliance solutions that eliminate the guesswork for international and domestic manufacturers. Global Registration Management: Successfully spearheaded over 200+ FDA registrations across the food, cosmetic, and medical device sectors. I manage the entire lifecycle of the FDA application, from initial DUNS number acquisition to final approval, ensuring zero administrative delays. Official US FDA Agent Representation: Currently serve as the designated US FDA Agent for dozens of foreign entities. In this capacity, I act as the authoritative liaison between the U.S. Food and Drug Administration and my clients, managing emergency communications and assisting during facility inspections. MoCRA Compliance Specialist: Achieved a 100% approval rate on complex registrations under the new Modernization of Cosmetics Regulation Act (MoCRA). I specialize in both cosmetic facility registration and electronic product listings, helping brands stay ahead of these recent legal mandates. Supply Chain & Import Optimization: I have streamlined the Prior Notice and import protocols for high-volume Amazon sellers. By implementing rigorous pre-shipment audits, I successfully reduced customs detention rates by 40%, saving clients thousands in storage fees and lost sales. Strategic Compliance Roadmaps: I develop bespoke compliance roadmaps for startups and SMEs, ensuring every product meets 21 CFR standards (including GMP and labeling requirements) well before their scheduled market launch. Audit & Warning Letter Resolution: I provide high-stakes support in responding to FDA Warning Letters and "Form 483" observations. My intervention has consistently helped businesses implement corrective actions, avoiding costly penalties and permanent import bans.
