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

EU Authorized Representatives  |  UK Responsible Person  |  FDA US Agent

AF Pharma Service's raison d'être is to solve the crucial regulatory situations our clients face in the EU acting as EU Authorized Representatives (EC Rep), UK Responsible Person (UKRP) and FDA US Agent for medical devices. Our unique methodology not only makes us different but is the reason for our success. Our expert consultants specialized in medical devices, machinery, cosmetics and nutraceuticals will provide you with the best service.

 

The core of our business is acting as medical devices EU Authorized Representatives (also called EU AR or EU Auth Rep), UK Responsible Person (UKRP), and FDA US Agent integrated with Regulatory consulting services provided by our local partners. We also are able to import your devices. Our clients are medical devices manufacturers, but also machinery, cosmetics and nutraceutical manufacturers. We will base our strategy in the best business for you acting as your medical device EU Authorized Representatives, UK Responsible Person, FDA US Agent and Importers. We provide the service of medical device Regulatory Responsible Person in our offices too.

As a leading provider of medical device regulatory services and medical device consulting, AF Pharma is your go-to resource for navigating the intricate world of medical device compliance. Whether you require an EU Authorized Representative, UK Responsible Person, or US Agent, our dedicated team possesses the capacity and regulatory know-how to propel your medical device company forward.

At AF Pharma Service, we understand the unique challenges faced by medical device manufacturers in today's global market. That's why we combine our extensive knowledge and skills to transform your medical device processes and strategies, ultimately driving the success of your company. Our expertise spans EU regulations, UK requirements, and US compliance, ensuring that we can guide you through every step of the regulatory journey.

As an EU Authorized Representative, we are proud to facilitate market entry for your medical devices in Europe. We bring deep understanding of EU MDR, IVDR, MDD, and IVDR certifications, allowing us to assist you in meeting the stringent regulatory standards set forth by European authorities. Likewise, as a certified UK Responsible Person, we have the expertise to help you navigate the UK medical device pathway, including obtaining the new UKCA mark. In addition to our European focus, we also serve as an experienced US Agent, supporting your efforts to bring medical devices to the United States. Our comprehensive knowledge of US regulations, including FDA requirements and submissions, empowers us to guide you through the complexities of the American market.

 

Work with AF Pharma Service to benefit from our proven track record of helping clients shape and bring their medical devices to both European and American markets. Contact us today to leverage our regulatory expertise and elevate your medical device company to new heights of success.

Call us today to schedule a meeting and provide you the best price to medical device EU AR, UKRP and FDA US Agent!

Medical Device Regulatory
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