Elevation SD
Elevation Strategic Development UK is a specialist regulatory and clinical development partner dedicated to precision medicine and Companion Diagnostics (CDx), supporting innovative companies in navigating complex global regulatory landscapes with confidence.
With extensive, hands-on experience in parallel drug–diagnostic development, Elevation UK has successfully guided CDx programs from early strategic planning through clinical evidence generation, technical documentation, and regulatory approval. Our team brings unparalleled expertise in translating IVDR requirements into practical, study-level implementation, as well as integration into pharma quality management systems. We are experts in ensuring clinical performance studies and combined drug–diagnostic trials are designed from the outset to meet European and global regulatory expectations.
With hands-on experience across diagnostic development, integration of diagnostics into drug trials, and regulatory review, Elevation UK bridges the gap between complex IVDR requirements and practical execution. We do not simply interpret regulation — we operationalise it, transforming regulatory complexity into clear, achievable actions that protect timelines, reduce risk, and deliver approval-ready companion diagnostics worldwide.
