IND Enabling Studies

Although guidance documents define the requirements for an IND, the uniqueness of every cell and gene therapy requires a tailored approach to submission. Let our experienced team of process development scientists and engineers, quality leaders, regulatory advisors, and manufacturing, supply chain and CMC experts help ensure a successful submission.

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WuXi Advanced Therapies_IND Support Studies

Specialized IND Support

Diverse and deep experience in CMC, regulatory, manufacturing, and testing come together to create an individualized path to support your IND submission.

Customized Approach

Timeline Acceleration

Broad Experience

In House Testing

Meet IND Submission Deadlines

We have the full spectrum of capabilities and facilities to support your IND-enabling study. From materials management and qualification to process development, testing and GMP manufacturing, our team will help ensure the CMC section of your IND submission is robust and aligns with regulatory guidance.
Let’s discuss your IND enabling study

Why Us?

Leverage our proven track record, experience, expertise, and facilities for a one stop solution to get to clinic faster.

Process Development

Integrated Testing

Project Management

Regulatory Resources

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