Navigating the complexities of Chemistry, Manufacturing, and Controls (CMC) regulations is critical for advancing gene therapies. Viralgen’s latest poster highlights their innovative approach to optimizing regulatory processes, ensuring streamlined approvals and faster patient access.
Key Highlights:
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Overcoming Challenges: Viralgen addresses hurdles such as inconsistent global regulations, high expectations from authorities, and a lack of specific guidance for gene therapy.
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Streamlined Solutions: By leveraging CMC templates, expert regulatory interactions, and a robust manufacturing platform, Viralgen has achieved 100% acceptance of submissions across multiple jurisdictions.
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Future Outlook: Viralgen envisions accelerating approval pathways, fostering harmonized global regulations, and leveraging data for streamlined compliance processes.
With 29 ongoing clinical trials supported by their CMC expertise, Viralgen is at the forefront of advancing regulatory efficiency in the rapidly growing gene therapy sector.
