ApexVera is a specialized regulatory consultancy supporting small and emerging biotechs with European and global clinical submission pathways.

Our experience includes EU CTR initial applications, IRIS submissions, pediatric planning, and coordination with regulatory authorities across programs in neurology, oncology, pediatric rare disease, and other complex therapeutic areas.

We focus on clarity, precision, and practicality — helping teams move forward without guesswork, whether they need support for a single submission or ongoing regulatory partnership.