Allele Biotech offers comprehensive consultation services tailored to cell therapy product development. With our wealth of expertise and industry knowledge, we offer a well-established framework to guide your team through every step of the process. Our mission is to support your team in ensuring that your early-stage cellular therapy products consistently meet high quality standards, adhere to the cGMP requirements, and comply with other regulations set forth by the US FDA. By leveraging our services, you can streamline the path to clinical trials, effectively managing both time and costs for your product development.
Consultation services includes but not limited to:
- Tissue Sourcing
- Institutional Review Board (IRB)
- Process Gap Analysis
- Process Development Planning
- Analytical Gap Analysis
- Analytical Development Planning
- Product Specifications Development
- Quality System Establishment
- SOP Writing
- Facility Design and Qualification
- Equipment Qualification
- Aseptic Qualification
- Process Validation
- Test Method Validation
- Environmental Monitoring Program Setup
- Personnel Training Program Setup
- Independent Audit
For more information, please contact us via email at info@allelebiotech.com.