Overview

We have over 30 years of experience with the FDA and leading regulatory bodies around the globe. Providing regulatory affairs, QA, CMC in the States, Europe, Brazil, India China and Israel - from R&D and early-stage startups to big pharma, we are highly experienced in a variety of pharmaceutical fields including vaccines, biologicals, cell therapies and ATMPs, botanical drugs, liposomes and medical devices, all in pursuit of treatment for an array of medical conditions. ADRES EU (Netherlands based) provides international startups access to the EMA interface, providing regulatory, financial and administrative assistance. Our European SME status allows us to conduct various actions on behalf of companies that are not registered in Europe but wish to benefit from EU financial incentives. From R&D to submission We were founded with the mission to assist early-stage startups in drug development processes, enabling them to foresee, tackle and cope with the challenges that arise along the way, in order to achieve successful results in line with the highest standards of leading regulatory bodies. Building Strategies that Translate to Success Drug-development companies often operate in vague and complex regulatory environments. Our extensive experience differentiates us from others in our ability to predict our clients' possible obstacles ahead of time, tailoring needed services to meet their current and future needs. We’ve been there, done that All of ADRES professionals bring hands-on experience from both industry and academia, translating into their ability to predict the best regulatory routes for clients, assess the complexity of their business environment and provide the right solution when in need. A one-stop-shop We tailor solutions for clients from A to Z, encompassing every needs they might encounter along the way. From early R&D phases, throughout the development process, production and market launch, we make sure the highest standards of strategy and implement