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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.
Let’s discuss your path to IND
Diverse and deep experience in CMC, regulatory, manufacturing, and testing come together to create an individualized path to support your IND submission.
Our experts engage with you to define the best IND enablement development, manufacturing and testing pathways.
Overlapping execution steps. deferring GMP readiness to post-submission and leveraging PD experts in early-stage manufacturing can shorten timelines.
Leverage our expertise in discovery, manufacturing, testing, and regulatory requirements for a variety of cell and gene therapies.
Safety, toxicology, and pathology are at the heart of IND studies. Our campus includes a testing facility to expedite results.
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
Leverage our proven track record, experience, expertise, and facilities for a one stop solution to get to clinic faster.
The unique characteristics of your product will define how our Process Development team optimizes and prepares your process for GMP manufacturing. Final IND enabling manufacturing is performed with PD oversight and participation as needed to reduce risk and meet submission timelines.
The unique characteristics of your product will define how our Process Development team optimizes and prepares your process for GMP manufacturing. Final IND enabling manufacturing is performed with PD oversight and participation as needed to reduce risk and meet submission timelines.
State of the art facilities and expert teams co-located on the same campus as process development and GMP manufacturing expedites the availability of data to support your CMC. Request a full menu of qualified and validated analytical test methods and release assays or discuss your requirements for custom assay development.
Meeting your major milestones and target dates for IND submission requires strict adherence to timelines, coordination of interdepartmental efforts, and the ability to identify gating factors and potential chokepoints. Our experienced project management team will help drive completion of all milestones by being the hub of project team communication and leading problem resolution.
Regulatory support includes advice at early stages of your project development as well as collaborating closely with you on submission documentation to FDA, EMA, NMPA or other agencies.