
beatrice
an FDA compliance expert
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FDA Drug & Cosmetic Regulatory Compliance Consultant
Freelancer.com • Freelance
Apr 2024 - Present • 2 yrs 6 mos
I support businesses preparing pharmaceutical and cosmetic products for the U.S. market by organizing regulatory information, reviewing documentation, and identifying applicable FDA compliance requirements. For drug products, my work includes organizing establishment registration information, drug listing data, labeler information, NDC-related documentation, product information, and labeling materials. I help clients identify missing information and prepare organized documentation for applicable regulatory processes. For cosmetic products, I assist with reviewing facility and product information, applicable MoCRA registration and listing considerations, ingredient information, labeling elements, warnings, business information, and product claims. I also conduct structured document reviews, create regulatory checklists, identify inconsistencies, and provide practical recommendations for improving compliance readiness. My work is focused on documentation quality, regulatory organization, and helping clients understand the requirements relevant to their products. I maintain a detail-oriented approach when handling regulatory information and communicate findings clearly so clients can make informed decisions about their U.S. market-entry preparation.