Accelerating Breakthroughs in BioMedicine
Expert Consulting for Innovative Life Science Ventures –
From Discovery to Commercialization
Biotech Consultancy Serving Global Clients
Since 2020 Partner with FDA Submission Experts & Research Strategy Leaders
- Value Proposition:
- 🔬 Precision Strategy Development
- 🧪 Regulatory Pathway Navigation
- 💊 Clinical Trial Design Optimization
- 🌐 Biotech Investment Readiness
What We Do
Specialized Consulting for Every Stage of Biotech Innovation
Research Design
· Protocol development
· Preclinical modeling
· Biomarker validation
Regulatory Strategy
· FDA/EMA pathway planning
· IND/IDE submissions
· Quality system implementation
Clinical Operations
· Trial site selection
· Patient recruitment solutions
· Data management
Core Services Table:
|
Service Category |
Key Offerings |
Deliverables |
|
Research Design |
Protocol development · Preclinical modeling · Biomarker validation |
Study-ready documentation packages |
|
Regulatory Strategy |
FDA/EMA pathway planning · IND/IDE submissions · Quality system implementation |
Gap analysis · Submission master files |
|
Commercialization |
Market analysis · IP strategy · Investor pitch coaching |
Valuation reports · Investor decks |
|
Clinical Operations |
Trial site selection · Patient recruitment solutions · Data management |
Monitoring plans · Recruitment forecasts |
Technology Specializations:
Therapeutic Areas
Gene & Cell Therapy
Precision Diagnostics
AI-Driven Drug Discovery
Medical Devices
*"Bio CC’s regulatory strategy cut our CAR-T IND approval time by 40%. Their FDA playbook anticipated every CMC question – first-cycle approval with zero clinical holds. We secured Series B funding before Phase I completion."* — Dr. Lucy Liu, CEO, OncoSynapse Therapeutics 📍 Therapeutic Area: Solid Tumor Immunotherapy ✅ Key Impact: $15M funding acceleration | FDA IND submitted in 100 days
