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Regulatory Expertise

Catalent has made significant investments in the cell and gene therapy space with strategic acquisitions and commitment to grow and innovate. Our quality and regulatory team have built a strong presence by combining leaders in the mature biologics business and emerging advanced therapeutics industry.

We implement fully-integrated teams across our biologics, cell, and gene therapy business areas that foster effective cross-collaboration and leverage each other’s competencies. This integrated approach has allowed us to offer full-service regulatory expertise from pre-IND to commercialization.

  • Real-time feedback from regulatory bodies stemming from high-volume submissions
  • Authoring expertise from INDs through BLA
  • Global publishing group with electronic documentation filing
  • In-country submissions in US/EU/Canada and support documentation for ROW
  • Emergency use authorization expertise