Regulatory Guidance Throughout Your CMC Journey

Our specialized knowledge in CGT regulatory affairs can help de-risk projects at any stage of development. With experience working with regulators around the world, we can deliver customized go-to-market cell therapy regulatory guidance and strategies.

Integrated Help at Every Step

We offer a full suite of cell therapy regulatory guidance consultation:

Interpretation and explanation of regulatory context
Assistance in developing regulatory plans to drive the commercialization strategy
Reduction of regulatory unknowns in project planning
Guidance and support throughout the preparation and submission process, including leading interactions with regulators such as US FDA and Health Canada
Regulatory support for manufacturing under GMP, including drafting and reviewing CMC sections of the regulatory submission

A Successful Track Record of Compliance

Powered by CCRM, we have a proven track record of navigating the regulatory landscape. We do so by working as an extension of your team. Our comprehensive regulatory plans identify efficiencies in time and resources, leading to the best outcome as fast as possible.