ADVANCED CELL & GENE THERAPY, Logo

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Service Area
International


Consulting Services

Overcome complicated and unique challenges in the development and commercialization of genetic therapy with ADVANCED CELL & GENE THERAPY. We provide assistance to biotechnology companies, clinical laboratories, and biotech investors in key problem areas, including:

• Evolving Regulatory Requirements
• Commercialization Strategy

• Product and Process Definition
• Biomaterials Sourcing and Control

• Clinical-Scale Process Development


We can assist you in development, GMP/GTP production, and regulatory compliance. Our team will analyze the feasibility of commercial opportunities to mainstream your research and capabilities.


Development

• Investigator and Clinical Site Selection Process Analysis and Optimization
- Maximize Cell Yield, Function
- High-Throughput Closed-Systems
- Enable Process Automation

GMP/GTP Manufacturing/QA

• Process and Analytical Method Qualification, Validation
• Laboratory Operations


Regulatory Compliance

• QA System Design
• Audits and Gap Analysis
• Pre-IND, IND, IDE Applications, Amendments

• Requirements, Applicability, Strategy

- FDA-CBER OCTGT, CDRH, AABB, AATB, FACT, NIH-RAC


Strategic Partnership and Investment Opportunities

• Scientific Due Diligence

• Evaluation Of Technical Expertise and Resource Sufficiency


Commercial Feasibility

• Analysis Of Potential Market
• Pathways To Regulatory Approval

• Potential for High-Throughput Commercial Manufacturing

• Potential Product Delivery Issues, Costs


Strategic Guidance, Monitoring

• Technical Validity

• Milestones and Progress