Advancing cell therapy programs requires quality systems and regulatory support that evolve alongside development and manufacturing activities. Our integrated QA, QC, and regulatory support teams work alongside development and manufacturing from day one, helping ensure compliance, maintain product quality, and support programs from early development through clinical filing and GMP manufacturing. With extensive ATMP regulatory expertise, we support IND/IMPD preparation and regulatory submissions as part of an integrated development and manufacturing strategy.
As part of our integrated Cell Therapy CDMO platform, quality and regulatory expertise are embedded throughout program progression to support successful clinical translation. Close collaboration across Quality, Regulatory, PD/AD, and GMP Manufacturing teams helps address critical considerations early and support smoother program progression.
Quality Systems & QC Capabilities
Robust quality oversight is essential for the successful development and manufacture of advanced cell therapies. Our quality framework supports consistency, compliance, and product release throughout the program lifecycle.
Capabilities include:
- Quality Assurance (QA) oversight
- In-house Quality Control (QC)
- Identity, viability, and potency testing
- Stability assessment and product characterization support
- Release testing and batch documentation
- Continuous quality and compliance review
- Full traceability across development and manufacturing activities
Regulatory Strategy & Submission Support
Leveraging extensive ATMP development experience and regulatory expertise, we support clients in navigating evolving regulatory requirements throughout clinical development.
Support includes:
- Regulatory strategy development
- Early engagement with regulatory authorities
- Guidance on ATMP-specific regulatory pathways
- CMC documentation support
- IND/IMPD preparation and submission support
- Regulatory support from development through clinical filing
Regulatory activities are closely aligned with our Process & Analytical Development and GMP Manufacturing capabilities, helping ensure that process understanding, quality considerations, and regulatory expectations remain connected throughout program progression
