Maria Duguine Carrasco

AF Pharma: Global Regulatory Support for Medical Devices, Cosmetics, and Supplements Registration for medical devices and cosmetics is our core expertise. We act as your EU Authorised Representative (EC Rep), UK Responsible Person (UKRP), US Agent for FDA, and TGA Sponsor in Australia. At AF Pharma, we understand the challenges of global market access and simplify the regulatory pathways for our clients. We provide strategic support to help you launch your products successfully and ensure ongoing compliance. Our services include: Registration of medical devices, cosmetics, and dietary supplements in the EU, UK, US, and Australia, Regulatory strategy development for global market access, CE marking (MDR/IVDR), UKCA marking, and FDA 510(k) submissions, Q-Sub preparation and FDA regulatory support, TGA and Health Canada registrations, Quality Management System (QMS) design and implementation (ISO 13485, ISO 9001, 21 CFR Part 111), Labeling and claims review for compliance and proper classification, Clinical and performance evaluation reports (CER/PER), Risk management files (ISO 14971), Post-market surveillance (PMS), vigilance reporting, and PSURs, Regulatory gap assessments and remediation plans, Cosmetic Product Information Files (PIF) and CPSRs for EU/UK compliance, Amazon compliance support for regulated product categories Our team has a strong track record of helping both startups and established manufacturers achieve regulatory compliance efficiently. We ensure you are always aligned with the latest requirements and act as your trusted partner every step of the way. Let AF Pharma guide you through complex regulations, so you can focus on innovation and growth.