Biotech Pharma Solutions

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