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Navigating the complexities of regulatory compliance is essential for life sciences companies looking to bring their products to market in the UK, EU, and beyond. At Regulatus we provide trusted in-country representative services (ICR) for each of the sectors we operate in, to meet regulatory requirements and remain compliant across jurisdictions.
Whether you’re entering the UK and need a UK Responsible Person (via our main company Regulatus Ltd), or entering the European Union market and need an Authorised Representative (via our wholly owned subsidiary MD Reps Ltd), our dedicated ICR service ensures you have a local, compliant point of contact with regulatory authorities.
Beyond the UK and EU, our extensive network of international partners ensures we can support your market entry and regulatory compliance across the globe. With our expertise, we provide seamless solutions for companies looking to expand into other regulated markets, including the United States, Asia, and the Middle East.
Our global services include:
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Expanding your business into new markets comes with the challenge of meeting complex importer obligations. At Regulatus we provide reliable regulatory importer services for all applicable sectors in which we operate.
A regulatory importer acts as the legal entity responsible for ensuring products imported into a specific market comply with all applicable laws and standards. Our services ensure you meet the regulatory requirements for having a designated importer in the UK and EU, without the need for setting up a physical presence.
Looking beyond the UK and EU? We’ve built an extensive network of international partners to act as your designated importer in regulated markets worldwide. From the United States to Asia and the Middle East, we can coordinate global regulatory importer services to streamline your international expansion.
Our worldwide support includes:
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At Regulatus we can offer expert support in the development of market access strategies, including:
