CONNECT INFORM ADVISE LAUNCH

Direct-to-consumer (DTC) products are all around us. The European market is world-renown for its great DTC companies or start-ups and such expertise should be shared with other countries. Just like other products, this billion-dollar industry is shaped by the regulatory environment that governs them. Amphion Health wants to help you with that. Drawing from our expertise about the regulatory and administrative requirements set by the Food & Drug Administration (FDA) for importation, we perform a qualitative review of your product and inform you of the steps necessary to regulate your product. Our multinational team of experts will also guide you in launching your product in the United States of America. We are Amphion Health. Let’s talk.

CONNECT INFORM ADVISE LAUNCH

Direct-to-consumer (DTC) products are all around us. The European market is world-renown for its great DTC companies or start-ups and such expertise should be shared with other countries. Just like other products, this billion-dollar industry is shaped by the regulatory environment that governs them. Amphion Health wants to help you with that. Drawing from our expertise about the regulatory and administrative requirements set by the Food & Drug Administration (FDA) for importation, we perform a qualitative review of your product and inform you of the steps necessary to regulate your product. Our multinational team of experts will also guide you in launching your product in the United States of America. We are Amphion Health. Let’s talk.

Founder

Victor Van de Wiele, LL.B., LL.M.

Victor is a legally-educated entrepreneur, with a focus on the regulation of therapeutics in both the United States and Europe. Through Amphion Health, he aims to offer clear-cut, tailored advice about the regulation of direct-to-consumer products including: cosmetics, vitamins, digital health applications. Victor draws from his background in both English and American law to offer clients succinct steps towards launching a product on the American consumer market.

Victor holds a bachelor’s degree in law from Queen Mary, University of London (UK) and masters’ degree in pharmaceutical law (LL.M.) from Georgetown University Law Center (US). He finished an academic research fellowship in pharmaceutical policy at Harvard Medical School (US) and now continues his research in pharmaceutical & intellectual property law at the Center for Law, Medicine & Life Sciences at the University of Cambridge (UK). Victor completed internships at Fieldfisher LLP and Johnson & Johnson in Brussels, Belgium and at the Food & Drug Law Institute (FDLI) and O’Neill Institute for National and Global Health Law in Washington DC (US).

Our services

Amphion Health offers qualitative and personalized advice concerning the regulation and importation of European direct-to-consumer products and telehealth applications in the United States. Examples of products include: cosmetics, vitamins, cannabinoids, food supplements. Our service intends to navigate clients through the several regulatory steps needed for a European company to launch in the US as mandated by the Food & Drug Administration (FDA). Additionally, we offer risk- and competitor analyses, administrative assistance, and clinical advice relying on the expertise of our team.

To ensure qualitative service, Amphion Health wants to understand you. We insist to connect on different levels with the client. What are your needs? What is your company’s vision? What is your product? What is your ambition within the United States market? How is your product regulated in the European Union? Let’s discuss.

Drawing from our expertise, Amphion Heath wants to inform you. About the different steps in the regulatory and business process. About the ways in which the FDA regulates your product. About the risks involved to your ambition. About your potential competitors in the field. About any specific questions you might have for us. We are here for you.

Since actions speak louder than words, Amphion Health wants to advise you. Based on research and the information you shared with us, we will provide a detailed action plan including: regulatory strategy, administrative documentation, risk analysis, competitor analysis, and importation/registration price tag. This plan constitutes our core product and sets the agenda for any further implementation you would like us to perform.

To ensure your launch is successful, we offer full technical support throughout the process. Our mutual goal is to ascertain market launch within the predicted time frame and to help you set up a successful business in the United States.

Team

Product speciality

Contact information

Amphion Health BV
Stijn Streuvelslaan 14
9840 De Pinte
Belgium

E. info@amphionhealth.com
T. +32 493 48 92 87