Case study: How MWB Consulting supports American drug developers entering the European market

We work with closely with our clients to identify which services they will benefit from, and we customise our work to meet their individual needs. For emerging American biotech companies, the regulatory market in the European Union (EU) can feel daunting.

American drug developers working with regulatory strategy consulting MWB Consulting can ease the process, reduce costs and timelines, and increase the chances of successful outcomes. In this article, we introduce a range of client cases to illustrate how we support US clients to successfully enter the European market.

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The clients

MWB Consulting have worked with a wide variety of US-based drug development start-ups and developers seeking marketing approval in the EU. Many were small organisations with limited budgets and tight deadlines, lacking regulatory teams and EU legislative expertise.

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Client spotlight

One US client wanted to start clinical trials in the EU with the eventual goal of marketing approval for their oncology development candidate. They didn’t have a registered office in the EU, so we acted as a sponsor’s legal representative in the region, providing them with a legal office for regulatory purposes. As they were eligible, we worked with them to secure EU small and medium-sized enterprise (SME) status, allowing them to access strategic advantages.

We guided them through the entire SME designation process, working with regulatory agencies with whom we’ve built trusted, long-term relationships. Successfully securing SME status offered them significant financial benefits, including lucrative fee reductions, waivers and additional support from the European Medicines Agency (EMA) – crucial to an emerging business with restricted budgets.

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Smoothing the process

With regulatory submissions and processes, success means procedures run smoothly, deadlines are met, and all objectives are achieved without unexpected complications. We achieve this by:

• Interpreting agency requirements and regulatory trends
• Creating agile submission strategies
• Preparing and reviewing documentation
• Managing applications and submissions with the relevant authorities
• Communicating directly with the EMA and Medicines and Healthcare Products
  Regulatory Agency (MHRA)
• Responding to queries, attending meetings, and offering expert post-meeting advice

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Client spotlight

We worked with a US-based client developing a drug for a rare disease. We supported the team, helping them gather appropriate epidemiological evidence and effectively structure their argument for unmet need. This resulted in them successfully obtaining Orphan Drug Designation in the EU.

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Multi-faceted expertise

Navigating the end-to-end regulatory process requires different skills and wide-ranging knowledge. Our team of consultants anticipates and navigates every challenge, creating a comprehensive roadmap that ensures smooth and predictable progress at a reasonable cost. By drawing on two decades of experience, we’ve helped our clients tackle:

• Completion of scientific literature reviews (SLR)
  We’ve helped developers comply with the EMA’s specific guidelines on conducting and documenting SLRs, ensuring they include all the required information in the correct format.
• Clinical Trial Information System (CTIS) submissions
  We’ve supported clients through the introduction of the Clinical Trial Regulation. As they navigate the current transition period, we’ve helped them master a range of new requirements quickly to avoid delaying their submissions.
• Scientific Advice Working Party (SAWP) procedures
  The SAWP offer scientific advice and protocol assistance to drug developers. To make the most of this, we’ve worked with our clients to plan effectively, ensure all documentation is completed correctly, prepare for meetings, and follow up on recommendations fully.
• Data protection requirements
  In today’s regulatory environment, data protection is becoming increasingly crucial, particularly for those conducting clinical trials. Our sister company, DPD, offers specialised data protection services that ensure our clients remain vigilant about their data protection obligations throughout the regulatory cycle.

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Client spotlight

Preparing for and submitting a Paediatric Investigational Plan (PIP) is a complex and involved process that can take more than twelve months. We worked with a client to develop a PIP for a novel therapeutic. We offered essential help and advice so they could successfully obtain a waiver and deferral and effectively structure their clinical studies.

• Pharmacovigilance compliance
  Our clients’ obligations don’t end when they secure marketing authorisation. That’s why we offer long-term post-authorisation solutions, including pharmacovigilance services. We act as a qualified person responsible for pharmacovigilance (QPPV) for many of our clients, freeing their internal teams from complex compliance processes, training requirements, time-consuming system set-up, and ongoing maintenance.

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Client spotlight

Through years of experience, we’ve refined our approach to become trusted advisors who can shape and execute our clients’ regulatory strategies. We build ongoing relationships to understand their unique needs and challenges so we can provide tailored and practical advice and action. Our team of pharmaceutical consultants understands the requirements of every phase of the development and regulatory approval process. That means we can offer support for just one phase or the entire process, working alongside existing teams as advisors or acting as representatives and taking full responsibility for all required actions. We build long-term relationships with our clients, often working over a number of years to complete a suite of projects. What may start with an SME application can develop into a comprehensive strategy for regulatory compliance that encompasses the whole process and beyond.