JW3 BioTechnologies LLC

JW3 BioTechnologies LLC: an SBA-Certified Women-Owned Small Business, also known as JW3 Bio® or JW3 Biotech®, is a Scientific and Technological Advisory Consulting Firm providing services in the fields of Biotechnology, Pharmaceutical R&D, Analytical Testing, Clinical Trials, Corporate Growth Strategy, Innovation & Growth Processes, Organizational Transformation, and Talent Management & Development Strategies • Provide strategic, operational, quality, regulatory, and CMC advisory consulting services to the US Federal Government and industries of Life Sciences, Biopharmaceutical, Pharmaceutical, Animal Health, Skincare, and Dermatology. • Provide executive management, project leadership, advisory consulting services, procurement strategies, talent development strategies and leadership mentoring in the fields of Biotechnology, Pharmaceutical R&D, Analytical Testing & Clinical Trials from clinical development through to commercial licensure of biologics, and drugs including monoclonal antibodies, fusion antibody proteins, recombinant human coagulation factors, cytokines, growth factors, therapeutics, vaccines, cell and gene therapy products. • Subject Matter Expertise (SME) in arenas of biologics, vaccines, cell and gene therapy: process development, scale up, global technology transfers, facility DQ, IQ, OQ, PQ, validation & start up, commercialization, drug launches, and large-scale CGMP manufacturing from clinical through to commercial manufacturing & distribution, quality & compliance, analytical testing strategy, regulatory submissions and inspection services with world-wide health authorities and regulatory agencies.