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nelson_stephe

Nelson Stephen

@nelson_stephe

Professional FDA Support for a Confident US Market Entry

United States
English, German, Italian, Spanish
About me
I help businesses navigate FDA compliance and regulatory requirements with confidence. My services include FDA registration, product listing, US Agent support, food facility registration, FSVP compliance, nutrition facts, supplement and food label reviews, MoCRA compliance, and medical device registration assistance. I focus on accuracy, attention to detail, clear communication, and reliable service. My goal is to make complex regulatory processes easier while helping businesses prepare their products for the US market. Let's work together to move your business forward!... Read more

Skills

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nelson_stephe
Nelson Stephen
Offline • 

See my services

FDA & Food Safety Clearance
I will handle fda registration, fda listing and regulatory compliance us agent
From$10 / projectMore details

Portfolio

Work experience

Registrar_Corp

FDA Compliance & Regulatory Affairs Specialist

Registrar Corp • Freelance

Nov 2024 - Jul 2026 • 1 yr 8 mos

As an FDA Compliance and Regulatory Affairs Specialist, I focus on supporting businesses with regulatory requirements for products entering the US market. My work involves understanding FDA regulations, reviewing product documentation, and helping businesses navigate food, dietary supplement, cosmetics, and medical device compliance requirements. My responsibilities include assisting with FDA food facility registration, FDA product listing, US Agent requirements, FSVP compliance, and regulatory documentation. I also work with nutrition facts panels, food labels, supplement labels, ingredient declarations, and product labeling reviews to help identify potential compliance gaps. In addition, I develop an understanding of cosmetic regulatory requirements, including MoCRA registration and product listing, as well as medical device establishment registration and device listing. I pay close attention to documentation accuracy, product information, labeling requirements, and regulatory updates. I also help identify missing information, review existing compliance documents, and provide practical recommendations based on applicable regulatory guidelines. My approach emphasizes professionalism, attention to detail, clear communication, and reliable client support. I understand that regulatory requirements vary depending on product category, manufacturing location, and intended market. My goal is to help businesses better understand their regulatory responsibilities, prepare accurate documentation, reduce avoidable compliance errors, and approach the US market with greater confidence.