Regulatory support for novel biopharmaceutical development

The service provides regulatory affairs support for novel biopharmaceuticals, including gap analysis, definition of a regulatory roadmap spanning preclinical studies, clinical trials, and approval, as well as support in seeking Scientific Advice from regulatory agencies. The duration varies depending on scope, with gap analysis typically requiring approximately three to four weeks, development of a regulatory roadmap taking three to six weeks depending on application complexity, and preparation for Scientific Advice taking up to three months, noting that final timelines depend on the internal schedules of the relevant regulatory bodies. The service is targeted at technology transfer offices and emerging biopharmaceutical companies, with the goal of enabling projects to understand regulatory requirements for development, clearly defining the studies and documentation needed to obtain clinical trial authorization and, ultimately, marketing approval. There are no formal phased stages, and activities are delivered through slide deck reports and video calls where findings and recommendations are discussed, alongside drafting of documents where relevant for specific regulatory interactions. The expected outcome is that EIC Pathfinder and EIC Transition beneficiaries will develop a clear understanding of regulatory requirements across development stages, including associated timelines and costs. Implementation is conducted remotely via document exchange and video conferencing.