Marcela R.

I help companies navigate international regulatory compliance for food, dietary supplements, cosmetics, chemicals, medical devices 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. 🩺 MEDICAL DEVICES • FDA device classification and regulatory pathway assessments • Class I and Class II medical device compliance • Regulation number, product code, and predicate device research • 510(k) readiness and regulatory gap assessments • FDA Pre-Submission / Q-Submission documentation support • FDA-recognized consensus standards assessment • Technical documentation and testing requirement reviews • Labeling, IFU, warnings, and claims compliance • Establishment Registration & Device Listing • U.S. Agent support for foreign manufacturers • QMSR / 21 CFR Part 820 regulatory gap assessments • Regulatory documentation supporting FDA submissions 💊 OTC DRUGS • OTC drug classification and regulatory pathway assessment • OTC Monograph compliance review • Active ingredient, strength, dosage, and indication assessment • Drug Facts labeling and claims review • FDA establishment registration and drug listing requirements • NDC / Labeler Code and SPL-related support • OTC product listing and regulatory documentation • Manufacturer / CMO documentation review • cGMP and regulatory gap assessments • FDA correspondence, remediation, and compliance support 🍽️ FOOD & DIETARY SUPPLEMENTS • FDA Food Facility Registration & U.S. 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 declarations • Ingredient, formulation, allergen & claims assessment • DSHEA and FDA/FTC claims compliance • FSMA compliance support • PCQI – Human Food 💄 COSMETICS • U.S. FDA cosmetic & MoCRA compliance • Cosmetic facility registration & product listing • Cosmetic vs. OTC drug classification • Ingredient / INCI and formula review • Labeling and claims compliance • Health Canada Cosmetic Notification Form (CNF) • EU CPNP & UK SCPN notifications • CPSR / PIF compliance coordination • EU/UK Responsible Person requirements 🧪 CHEMICALS & CONSUMER PRODUCTS • Safety Data Sheets (SDS), OSHA & GHS compliance • Household, commercial & industrial cleaning product compliance • California Proposition 65 • CPSC / CCPSA regulatory assessments • GCC / CPC requirements & CPSC eFiling • CE / UKCA applicability assessments • Product labeling, warnings & testing requirements ⚠️ FDA ENFORCEMENT, IMPORT DETENTIONS & REMEDIATION • FDA detained shipment release support • Form FDA 766 – relabeling/reconditioning applications • FDA compliance gap assessments and corrective-action planning • Responses to FDA regulatory requests and follow-up communications • Misbranding and labeling remediation • Import Alert / DWPE removal support • Review and preparation of supporting regulatory documentation 🌎 GLOBAL REGULATORY & MARKET ACCESS In addition to the U.S. market, I support regulatory projects involving Canada, the European Union, the United Kingdom, including product classification, labeling, registrations and notifications, import requirements, Responsible Person / Authorized Representative requirements, and market-entry compliance. My goal is not simply to cite regulations, but to translate them into a clear and actionable compliance strategy that manufacturers, laboratories, designers, quality teams, and business owners can follow. COMMUNICATION & WORKFLOW: I work primarily through written communication via Upwork to ensure accuracy, efficiency, and proper documentation of regulatory requirements. All pre-contract discussions, project scoping, and technical clarifications are handled in writing. Live meetings are not part of my standard workflow and may be arranged exceptionally for active projects when necessary. * Regulatory services are based on the information and documentation provided, do not constitute legal advice and do not guarantee regulatory clearance or approval.