Marcela R.

Head of Regulatory Compliance

I help companies navigate international regulatory compliance for food, dietary supplements, cosmetics, chemicals, and consumer products entering the US, Canadian, EU, and UK markets. ⭐ Top Rated on Upwork | 5-Star Client Feedback 🌎 500+ clients and brands supported internationally I work with startups, established brands, manufacturers, and importers to identify applicable regulatory requirements and provide practical, product-specific compliance support. 🍽️ FOOD & DIETARY SUPPLEMENTS • FDA Food Facility Registration & US Agent services • FSVP (Foreign Supplier Verification Program) • FDA Prior Notice & import compliance • Food & supplement labeling for U.S., Canada, EU & UK • Nutrition Facts, Supplement Facts, Canadian Nutrition Facts Table & EU/UK nutrition declaration review • Ingredient, formulation, allergen & claims assessment • FSMA compliance support • PCQI - Human and Animal Food 💄 COSMETICS • US. FDA cosmetic & MoCRA compliance • FDA facility registration & cosmetic product listing • Health Canada Cosmetic Notification Form (CNF) • EU CPNP & UK SCPN cosmetic notifications • Cosmetic labeling, ingredient & claims review • OTC vs. cosmetic classification assessment • CPSR compliance support • EU/UK Responsible Person requirements 🧪 CHEMICALS & CONSUMER PRODUCTS • Safety Data Sheets (SDS), OSHA & GHS compliance • Cleaning & household product compliance • California Proposition 65 (Prop 65) • U.S. & Canadian consumer product safety assessments (CPSC / CCPSA) • GCC/CPC requirements & CPSC eFiling • CE/UKCA applicability assessments • Product labeling, warnings & testing requirements FDA IMPORT DETENTIONS & ENFORCEMENT • FDA detained shipment release support • Form FDA 766 – relabeling/reconditioning applications • Corrective actions for misbranding and other compliance violations • FDA detention responses, evidence & regulatory submissions • Import Alert / DWPE removal petitions • Support with FDA communications and import compliance issues 🌎 INTERNATIONAL COMPLIANCE I support regulatory projects across the United States, Canada, European Union, and United Kingdom, including product classification, labeling, registrations and notifications, import requirements, Responsible Person/Authorized Representative requirements, CE/UKCA, WEEE/EPR, and market-entry compliance. My goal is simple: determine what applies to your product, what does not, and what needs to be done before you enter the market, helping you export with confidence while reducing the risk of detentions, penalties, compliance issues, and costly delays. If you are launching, importing, or selling a regulated product, send me your product details, target market, and what you need help with. *Regulatory services are based on the information provided, do not constitute legal advice, and do not guarantee regulatory approval.