Navigating complex regulatory requirements (FDA, EMA)
Ensuring product consistency, purity, and absence of contaminants
Managing supply chain for critical clinical materials
Breakthroughs in Technical Bottlenecks: Enhancing Plasmid Amplification Stability and Overcoming mRNA Process Limitations
plasmids for viral vector production or DNA vaccines.
Extensive testing suite including identity, purity, potency, sterility, and endotoxin levels.
Preparation of Drug Master Files (DMF) and Certificates of Analysis (CoA)
Facilities and processes designed to meet regulatory standards.
Robust QMS ensuring product traceability and consistency.
Experience supplying materials for INDs and clinical trials
Collaborative support throughout the product development lifecycle.
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