BioStrategic Consulting Ltd provides a range of management-level clinical development consulting services to the pharmaceutical, biotechnology and medical device industries, including:
• Clinical development strategy and management, especially for development-stage companies
• Conceptualization, implementation, and management of Phase 1, Phase 2, first-in-man, and proof-of principle clinical trials
• IND planning and preparation
• FDA and other regulatory authority submissions, meetings, and related interactions
• Clinical strategic planning for small molecules, biotechnology products, immunotherapeutic agents, novel drug delivery technologies, and medical devices in virtually all therapeutic areas
• New technology assessment, due diligence, and program planning
• Clinical development advisory services to senior-level management (CEO, COO, CSO, BOD).
Specialties
Clinical/regulatory strategy for new drugs and biologics, Clinical protocol development and management, New technology assessment, due diligence, and program planning, Clinical operations oversight
