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.
Featured Case Study
Nkarta Collaboration Achieves Cost-Effective Manufacturing in Tight Timelines
As a CCRM subsidiary, OmniaBio is building on an established foundation and reputation in manufacturing for cell and gene therapies, expanding on a knowledge base and legacy that has been built over a decade. Together, we are meeting the needs of our CDMO customers. In a project that achieved cost-effective manufacturing under tight timelines, our team delivered as a CDMO partner for clinical-phase manufacturing of a natural killer (NK) cell product for Nkarta.
Support in Every Area of Expertise
Immunotherapy
Best-in-class solutions for cell therapy development and manufacturing
Lentiviral Vectors
Enhancing gene delivery through end-to-end developmental support
