Expert Guidance in Cell and Gene Therapy

Genesis CMC offers consulting in scientific, regulatory, clinical and manufacturing areas guiding biotech startups and pharma companies in developing innovative therapies. On-site services available in the US and EU.

Our Expertise

Regulatory Strategy & Filings
Navigate the complexities of health authority requirements and prepare essential CMC documentation for regulatory submissions.
Manufacturing & Tech Transfer
Fit-for-purpose manufacturing strategy to support program goals and budgets.
Supply Chain Management
Coordinate all aspects of supply, including vendor selection, storage and shipment oversight, depot management, and import / export.
Analytics
Develop strategies for analytical method development, stability studies, device qualification, and comparability approaches.
Quality Assurance & Compliance
Implement robust QMS ensuring product safety and compliance throughout the development process.
Clinical Trial Support
Tailored clinical protocols ensure patient safety and compliance with gene therapy guidelines, to enhance trial efficacy.

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