CELL & GENE CONSULTING.
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Product Development & CMC Consulting Services for Companies in the Advanced Therapies Industry
Product Development & CMC Consulting Services for Companies in the Advanced Therapies Industry
Fit-For-Purpose, by Design.
An End-to-End Experience
An End-to-End Experience
from Early Development to Late-Stage Clinical Trials
from Early Development to Late-Stage Clinical Trials
Founded in March 2024, Cell&Gene Consulting Inc. has been supporting cell and gene therapy organizations to bring more advanced therapies to the clinic by translating discoveries and technical innovations into a clinic-ready reality through strategic advice and a pragmatic, result-driven approach to CMC product development and GMP manufacturing operations.
Our Client Portfolio at a Glance
Our client portfolio comprises small and large biotechs, contract organizations, enabling technology companies and investor firms working on developing assets and services in the advanced therapy industry.
Our clients are working on cell therapy and gene therapy products (such as T cell products, engineered macrophages, in vivo CAR-T therapies and iPSC-derived tissues) but also on enabling technologies (such as next-generation bioreactors and automated devices) or on advanced services supporting commercialization of cell and gene therapies.
They are located in Canada, the US, Europe, the UK, Asia and Australia. We therefore developed
knowledge of regulatory requirements for Health Canada, the FDA, the EMA, the HMRA and the TGA, allowing for a smooth transition from one jurisdiction to another .
Services at a Glance
Product Development
and CMC Strategy
GMP Manufacturing
of Clinical Products
Process Development
and Automation
Quality Management Systems
and Quality Assurance
Analytical Development
and Qualification
CMC Writing
Tech Transfer
into a GMP Setting
Product Characterization
and Translational Sciences
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