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Automated Vaccine Production

Drug Manufacturing Strategy

We bridge the gap between research and scalable production, ensuring manufacturing strategies align with trial timelines, quality standards, and regulatory compliance.

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CMC & Process Development

  • Early-stage Chemistry, Manufacturing, and Controls (CMC) planning.

  • Technology transfer and process validation for clinical batches.

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Vendor Qualification & Oversight

  • GMP audits, quality reviews, and performance benchmarking.

  • Risk-based vendor selection for reliability and compliance.

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Lifecycle Documentation & Compliance

  • Creation of regulatory-ready CMC documentation for Phases I–II.

  • Change control management integrated within cintl.ai for transparency.

 

Outcome      Compliant, scalable, and inspection-ready manufacturing that supports faster progression to late-                            phase development and commercialization.

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