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