Konexio Biotech

Konexio Biotech is an active Spanish-based 360° consulting firm specializing in technical-regulatory advice for innovative therapies including synthetic and biological medicines, advanced therapies, medical devices, and diagnostics. They provide end-to-end support to biopharma startups, pharmaceutical companies, research centers, hospitals, and investors—covering facility design/equipment setup, preclinical/clinical trial strategy/execution per regulations (GxP), regulatory affairs/dossier preparation for EMA/FDA submissions or CE marking of devices/cosmetics/medicines. Their multidisciplinary team includes experts in molecular/cellular biology, omics sciences (proteomics/genomics/metabolites), bioinformatics/statistics as well as pharmaceutical engineering and quality/compliance. They are recognized for their educational initiatives on regulatory changes such as ATMP manufacturing requirements.