Beyond Compliance: Turning Regulatory Strategy into Competitive Advantage

As regulatory expectations continue to evolve, medtech and pharmaceutical companies must adopt strategies that go beyond compliance. This white paper explores how regulatory strategy can be used not only to meet requirements but to create competitive advantage. It outlines key considerations for effective planning, including early engagement, strategic use of incentives, and collaboration with global regulators.

Supported by real-world case studies, it demonstrates how early regulatory input can reduce risk, accelerate development, and support critical milestones such as funding and acquisition. Whether you’re a startup or an established company, this paper offers practical insights to help turn regulatory complexity into opportunity.

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Meet the Authors

Liz Morgan, Associate Director & Principal Regulatory Consultant, DLRC

Liz joined the company in 2019 and has over 23 years of experience working in global regulatory affairs. In addition to being a Team Leader, Liz has provided EU and US regulatory expertise to clients for various projects and therapeutic areas, including rare paediatric diseases. Support has included regulatory leadership, strategy and advice, Centralised MAA, and US BLA & NDA, global clinical trial authorisations, national, EU and US scientific advice and due diligence. Prior to joining DLRC, Liz held positions in regulatory affairs at Mylan and Pfizer. Additionally, Liz has a BSc in Biotechnology.

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Dawn Spark, Principal Regulatory Consultant, DLRC

Dawn joined DLRC in 2021 with many years of experience in Regulatory Affairs, with particular expertise in clinical development leading to MAA submissions. Specifically, this includes advising on strategy for orphan drug designation, paediatric plans, scientific advice and regulatory authority interactions. Most recently, while at DLRC, Dawn has worked with several clients to file MAAs to the MHRA, both as national MAAs and via the International Recognition Procedure.

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