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grace_regi

Grace Coleman

@grace_regi

FDA Regulatory Consultant, FDA Registration, 510k Submissions, Compliance Expert

United States
English, French, German, Dutch, Italian, Spanish
About me
I help manufacturers, brands, and startups successfully enter the U.S. market through expert FDA regulatory consulting and compliance support. My services include FDA Registration, 510(k) submissions, MOCRA cosmetic listing, import permits, U.S. agent services, product label compliance, and regulatory documentation. I also design FDA-compliant peptide, nutraceutical, and supplement websites using WordPress and WooCommerce. With a focus on accuracy, efficiency, and clear communication, I deliver reliable solutions that help businesses achieve compliance and launch with confidence.... Read more

Skills

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grace_regi
Grace Coleman
Offline • 
Average response time: 1 hour

See my services

Writing & Translation
I will fda registration, import permit, compliance for food, cosmetics, medical device
From$30 / projectMore details
WooCommerce
I will build fda compliant peptide store, website with airwallex payment setup
From$85 / projectMore details

Work experience

Redefine_Meat

Senior FDA Regulatory Compliance Consultant

Redefine Meat • Freelance

Jan 2021 - Aug 2024 • 3 yrs 7 mos

Provided end-to-end FDA regulatory consulting services for manufacturers, startups, and international businesses entering the U.S. market. Managed FDA Establishment Registration, Device Listing, 510(k) submissions, U.S. Agent services, import permits, label compliance reviews, and regulatory documentation. Assisted clients in meeting FDA requirements efficiently while reducing compliance risks and avoiding costly delays. Successfully supported multiple product launches across medical devices, dietary supplements, cosmetics, and food sectors

Tech_Hub

FDA Compliance Website & eCommerce Specialist

Tech Hub • Freelance

Nov 2020 - Jul 2023 • 2 yrs 8 mos

Designed and developed FDA-focused websites for peptide, supplement, cosmetic, and health-related businesses using WordPress and WooCommerce. Created compliant product pages, implemented regulatory-friendly content structures, optimized user experience, and integrated eCommerce functionality. Collaborated with business owners to ensure websites aligned with industry regulations while maintaining strong branding, conversion rates, and professional online presence.