Regulatory Strategy
We guide you through complex EU and global regulatory landscapes with clear, actionable strategies.
From early classification and intended use definition to clinical evidence planning and submission pathways, we ensure your device or IVD meets MDR, IVDR, UKCA, CE, and FDA requirements.
Our team combines regulatory insight with clinical and statistical expertise to streamline approvals, reduce risk, and position your product for long-term compliance and market success.
Study Design & Protocol
A winning regulatory strategy, a solid study design, and a protocol that works at site — not just on paper
A strong study begins with alignment between regulatory requirements, scientific objectives and real-world feasibility. We help you define the right strategy from the start, ensuring compliance with EU MDR / IVDR, UKCA, CE and FDA requirements.
Our team translate regulatory and clinical needs into robust, practical protocols that tie everything together; from biostatistics and endpoints to site and patient considerations. The result is a de-risked study design that accelerates approvals, avoids costly rework and lays the foundation for future evidence, including post-market follow-up.
Study Startup
From contracts to submissions, we prepare your study for success and accelerate first-patient-in
The startup phase sets the pace for your entire study. We streamline this critical stage to launch your device study quickly and compliantly, managing regulatory and ethics submissions, site contracts and budgets. With in-country experts across multiple regions, we navigate local regulations, cultural nuances, and language requirements to prevent delays.
Leveraging strong site and regulator relationships alongside our proprietary AI-powered regulatory tool, we improve document quality, accelerate approvals and maintain compliance. The result: your study moves from planning to patient enrolment faster, with timelines kept tight and no compromise on quality.
Site Selection & Monitoring
Experienced investigators, access to the right patients and rigorous oversight throughout
The choice of sites can make or break a study. Using our extensive site network, we select high-performing investigators with access to the right patient populations and proven experience in medtech studies, ensuring enrolment targets are on track and on time.
Once sites are active, our monitoring team provides proactive oversight to safeguard patient safety, ensure protocol adherence and maintain data integrity. With consistent communication and early risk detection, we prevent costly deviations and keep your trial inspection-ready at every stage. The result is quality oversight that gives you confidence in your sites, your data, and your study outcomes.
Clinical Study Management
Hands-on leadership to keep your study on track, and your team updated every step of the way
Our experienced study managers have led dozens of global device and diagnostics studies across more than 50 countries in a wide range of indications and disease areas. We understand the complexities of medtech studies and provide comprehensive oversight of global teams, sites, data, budgets and safety throughout the trial.
Our proactive study management team ensure visibility of progress, responsive communication and consistent delivery against timelines. The result: a study that runs smoothly, stays compliant and generates the reliable evidence you need for regulatory and commercial success.
Data Management & Biostatistics
Clean data, actionable insights and the analysis you need for regulatory success
A robust dataset is the backbone of credible evidence. Our data management team builds efficient databases, manages queries and ensures data integrity throughout your study. In parallel, our biostatisticians are integrated at every stage, from protocol design and database development through to interim analyses, final reports and regulatory submissions.
This end-to-end approach means your data are not only clean but analysed and presented to the highest scientific and regulatory standards. The result is clear, defensible outcomes you can rely on for decision-making and regulatory approval.
Medical Writing
Clear, compliant and compelling documents for every step of your device’s journey
Well-written documentation is critical to the success of any medtech study. Our team has extensive experience producing audit-ready documents that meet regulatory requirements and scientific standards. From protocols, Investigator’s Brochures and informed consent forms to evaluation plans, study reports and regulatory submissions (FDA or notified bodies etc), we deliver clear, accurate and compliant outputs.
We also review existing materials to ensure consistency with ISO standards, EU MDR/IVDR, FDA and UKCA requirements. By combining scientific expertise with regulatory insight, we make complex data clear and credible — building confidence with regulators, clinicians and patients.
Book your free consultation with our clinical experts
We offer free clinical and regulatory consultations to discuss your device or diagnostic’s pathway, strategy and study needs. Whether you’re planning your first investigation or navigating post-market requirements, our experienced team look forward to answering your questions, understanding your goals and sharing insights. This is a no-pressure conversation designed to help you move forward with clarity and confidence. Trusted by medtech innovators across Europe, Asia and the US.
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