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ÀÖÓ㣨Leyu£©ÌåÓý¹ÙÍø’s Life Science Regulatory Solutions Practice is a full-service regulatory and product development consulting group. The specialist team of experienced regulatory affairs professionals offers technical regulatory advisory services throughout the product life cycle for biologics, Cell and Gene Therapies (ATMPs). pharmaceuticals, medical device and diagnostic companies globally. Our centre of regulatory excellence provides life science companies extensive Non-clinical, Chemistry, Manufacturing and Control (CMC) and Clinical development expertise; providing a risk based approach to navigating the regulatory requirements of product development across the EU, UK, US, Asia, South America and the rest of the world and helping life science companies maintain their product licenses across global markets.

Our regulatory experts have a deep understanding of product development strategy, risk management and the rate limiting steps in product development and launch. We support life science companies to identify optimal Target Product Profiles (TPP) for key assets and to achieve their commercial goals through phase appropriate study design.

The Life Science Regulatory Solutions Practice at ÀÖÓ㣨Leyu£©ÌåÓý¹ÙÍø can offer clients a suite of commercial regulatory and strategy services, for example: early commercial planning and forecasting, innovative marketing and promotions, portfolio value maximisation, innovative access and pricing, integrated go-to-market strategy, patient strategies, regulatory compliance and solutions; and product launch and commercialisation.