컨설팅내용
~ Well-differentiated formulation Development
~ Pharmaceutical New Product Development strategies
~ Patent Non-Infringing formulation and process development
~ Conceptualization/Ideation, Feasibility Studies
~ Competitive Intelligence and Investment De-Risking Strategies
~ CMC /CTD/ eCTD Development and review
~ IMPD/IND/NCE opportunities - 505(b)(1) products
~ NDA opportunities - 505 (b)(2) products
~ ANDA - 505 (j), First-To-File Products & Paragraph IV product opportunities
~ Novel Drug Delivery Systems - NDDS Products
~ Proprietary Formulations and Platform Technologies Development
~ Unmet Medical Needs Assessment
~ Real-World-Examples and Commercial Assessment
~ Product Life-Cycle-Management (LCM) Strategies
~ Health Economics and Outcomes Research (HEOR) Analysis
~ Product Portfolio building
~ Rare/Orphan Drug Development opportunities
~ Revival of "Dead Clinical Assets” by applying Multi-Disciplinary Technological Approaches
~ Managing Teams of Multidisciplinary Scientists
~ Product Development Budgeting, Timelines and Project Management
~ Scale-Up, Validations and Technology Transfer
~ KOL Profiling & Engagement as per product requirements
~ Clinical Supplies, CRO, and CDMO Engagement