Consulting Services
Expert Advisory Across the Full Development Continuum
From preclinical design to market access, CellTC provides end-to-end strategic guidance for cell and gene therapy programs.
Clinical Development Strategy
Phase I–III trial design, endpoint selection, and adaptive protocol development for cell therapy programs.
- Study design and protocol development for autologous and allogeneic cell therapies
- Endpoint selection and biomarker strategy aligned with regulatory expectations
- Adaptive trial design and interim analysis planning
- Clinical operations and site selection advisory
- Data management and statistical analysis plan review
Regulatory Pathway Advisory
FDA, EMA, and global regulatory strategy including IND/CTA preparation and agency meeting support.
- IND and CTA preparation and submission strategy
- Pre-IND, Type A/B/C meeting preparation and agency interaction support
- Breakthrough Therapy, PRIME, and RMAT designation applications
- Orphan Drug and Fast Track designation strategy
- Global regulatory harmonization for multi-regional programs
Manufacturing & CMC Consulting
Process development, scale-up strategy, and CMC documentation for autologous and allogeneic platforms.
- Process development and optimization for cell therapy manufacturing
- Scale-up strategy from research to clinical and commercial scale
- CMC section preparation for regulatory submissions
- Quality systems and GMP compliance advisory
- CDMO selection and technology transfer support
Preclinical Program Design
In vitro and in vivo study design, biomarker strategy, and translational research planning.
- Mechanism of action and proof-of-concept study design
- In vivo efficacy and safety model selection
- Translational biomarker identification and validation strategy
- IND-enabling study planning and GLP compliance
- Preclinical-to-clinical translation gap analysis
Market Access & Reimbursement
Health economics, payer strategy, and value dossier development for advanced therapy medicinal products.
- Health technology assessment (HTA) strategy and submission planning
- Payer landscape analysis and reimbursement pathway mapping
- Value dossier and HEOR evidence generation planning
- Outcomes-based contracting and risk-sharing model design
- Patient access program development
Our Methodology
Science-driven. Strategically precise.
Every engagement begins with a rigorous scientific review of your program's data, competitive landscape, and regulatory environment. We build strategy from evidence — not templates.
Program Assessment
Comprehensive review of existing data, regulatory history, and development gaps.
Strategic Roadmap
Tailored development plan with clear milestones, decision points, and risk mitigation.
Execution Support
Hands-on advisory throughout implementation — from protocol drafting to agency meetings.
Discuss your program with our team.
Schedule a confidential consultation to explore how CellTC can accelerate your cell therapy development.
For qualified medical and research institutions only.