Cell and gene therapies represent a new frontier in medical science, offering transformative solutions for rare, orphan, and previously untreatable diseases. Further, the potential of personalized medicine through working with a patient’s own cells opens up incredible potential for therapeutic intervention. The complexity of these personalized medicines demands sophisticated regulatory strategies and demanding quality standards. Compliance Architects specializes in navigating this complexity, helping companies achieve long-term success through tailored regulatory solutions and proven development, manufacturing and quality expertise.
Compliance Architects provides a full complement of services designed to meet the unique demands of cell and gene therapy development, tech transfer and commercialization. Our team works closely with your organization to implement phase-appropriate, resource-efficient solutions that ensure compliance and operational excellence.
Our team includes industry leaders with decades of experience in cell and gene therapy, biopharmaceuticals, and regulatory compliance.
A pioneer in cell and gene therapy, Diluks led Novartis’ commercial CAR-T (KYMRIAH) quality manufacturing organization, overseeing operations across the US, EU, and APAC. His expertise spans quality operations, regulatory strategy, and cross-functional collaboration, driving innovation and excellence.
With over 25 years of leadership at Johnson & Johnson, Teresa brings extensive experience in quality management, FDA inspections, and compliance for biotechnology, cell-based products, and pharmaceutical dosage forms. Her expertise spans all GxPs, ensuring operational excellence across diverse product categories.
The Cell and gene Therapy (CGT) industry is experiencing rapid growth. It offers...
Since 2021, the Pharma Manufacturing World Summit has gathered SVPs and VPs of...
Introduction Cell and gene therapy evolution has undergone remarkable advancements, transforming the landscape...
Drive innovation and ensure compliance with our expert guidance. Compliance Architects delivers tailored regulatory strategies and quality solutions to help you succeed in the transformative field of cell and gene therapies.
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