From Principle to Practice: The Business of Science driving science to marketable products. We specialize in FDA Regulatory Affairs; Business Development;Clinical Development (Phase 1-4); and Scientific Leadership • FDA Regulatory Affairs and compliance for drugs, medical devices/510(k), biologics, nutraceuticals, etc. • FDA pathways in IND/NDA/BLA, IDE/PMA, 510(k), IVD, ANDA, etc. • Business development for strategic partnering, product development, team building and USA/international partnerships • Scientific Director/Chief Scientific Officer driving therapeutic areas, medicinal chemistry/CMC/CGMP, program management, and pharmacology/posology/ADME, safety and efficacy • Medical writing, scientific writing, FDA documents, presentations and invited lectures