AF Pharma Service Regulatory services
for Medical Devices, Cosmetics and More

EU Authorized Representatives  |  UK Responsible Person  |  FDA US Agent

AF Pharma Service's core mission is to address critical regulatory challenges within the EU, serving as EU Authorized Representatives (EC Rep), UK Responsible Persons (UKRP), and FDA US Agents for medical devices. Our distinctive methodology, coupled with the expertise of our consultants specialized in medical devices, machinery, cosmetics, and nutraceuticals, ensures unparalleled service quality. As an integral part of your business, we seamlessly integrate as EU ARs, UKRPs, and FDA US Agents, complemented by regulatory consulting services. Catering to medical device manufacturers, as well as machinery, cosmetics, and nutraceutical producers, we tailor strategies to your specific needs.

​

In addition to our regulatory services, we are proud to hold Health product manufacturer climate certifications, underscoring our commitment to eco-conscious practices throughout the manufacturing process. By partnering with AF Pharma Service, you not only ensure regulatory compliance but also align with a company dedicated to sustainability.

​

With a profound understanding of EU, UK, and US regulations, we adeptly navigate the complexities of compliance, propelling your company towards success. As your EU AR, we facilitate European market entry, boasting expertise in EU MDR, IVDR, MDD, and IVDR certifications. Similarly, our UKRP services encompass guidance through the UK medical device pathway, including the UKCA mark. Additionally, as experienced US Agents, we facilitate market access in the United States, adept in FDA requirements and submissions.

​

Partner with AF Pharma Service to benefit from our proven track record, guiding clients to success in European and American markets. Contact us today to harness our regulatory expertise and propel your medical device company to new heights.

Schedule a meeting to receive the best pricing for medical device EU AR, UKRP, and FDA US Agent services!