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rosecharles234

ROSE CHARLES

@rosecharles234

FDA PRO

Verenigde Staten
Engels
Sommige informatie wordt in het Engels weergegeven.
Over mij
I'm Rose Charles, an FDA Compliance Expert helping businesses meet U.S. regulatory requirements without delays or rejections. I handle FDA 510k submission, device listing, NDC, OTC registration, and full compliance support. I also review food, supplement, and medical labels for FDA compliance and accuracy. For global clients, I provide FDA US Agent services, product listing, and registration for food, cosmetics, and Amazon sellers. Reliable, audit-ready, and results-driven. Message me now to stay fully compliant. Thank you... Lees meer

Skills

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rosecharles234
ROSE CHARLES
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Bekijk mijn diensten

Goedkeuring FDA en voedselveiligheid
I will handle fda product listing, fda registration and fda compliance
Bedrijfsregistratie
I will fda US agent, compliance for food, cosmetic, non US companies, amazon sellers

Portfolio

Werkervaring

UL

FDA Regulatory & Compliance Specialist

UL

Jan 2026 - Mar 20262 mos

I specialize in end-to-end FDA compliance services for food, dietary supplements, cosmetics, medical devices, and OTC products. I help manufacturers, importers, startups, and Amazon sellers navigate FDA regulations and meet U.S. market entry requirements with confidence and accuracy. My work includes detailed FDA label reviews for food, supplement, and medical products. I assess product labels for compliance with FDA regulations, including ingredient declarations, nutrition and supplement facts panels, allergen statements, claims review, and proper formatting. I identify non-compliant claims, misleading statements, and labeling gaps to help clients avoid regulatory actions and market delays. I manage FDA registration and product listing for both domestic and foreign companies, ensuring proper establishment registration, product classification, and submission accuracy. I also support clients with FDA 510(k) submissions for medical devices, including device classification, regulatory pathway analysis, and technical documentation preparation. Additionally, I assist with device listing, establishment registration, and ongoing FDA compliance obligations. I support OTC and drug-related compliance, including NDC registration and labeling compliance. My services also include acting as an FDA US Agent for non-U.S. companies, managing regulatory communications, and ensuring foreign facilities meet FDA requirements for U.S. market entry. Beyond registration and submissions, I help businesses implement compliance strategies across their supply chain and product lifecycle, reducing risk and ensuring ongoing regulatory alignment. I work closely with clients to resolve compliance challenges, respond to regulatory concerns, and prepare audit-ready documentation. My focus is accuracy, compliance, and smooth market access, helping clients avoid delays, costly mistakes, and enforcement actions while confidently entering or expanding in the U.S. market.