Keep your gene therapy development on track
The paradigm of regenerative medicine development is changing. Expedited regulatory approvals can help developers, but only if they are timely with strategic planning and fully versed in the latest or upcoming regulatory requirements.
Being ready to move forward expediently after regulatory approval means you need to fully explore endpoints, start planning for value dossiers, and begin developing a market access strategy prior to your gene or cell therapy or tissue-engineered product obtaining regulatory approval.
If your advanced-therapy product has received fast-track designation, like the US FDA’s Regenerative Medicine Advanced Therapies (RMAT) or the EMA’s Advanced Therapy Medicinal Products (ATMP) designations, getting a jump on this planning is even more critical.
You can depend on our experienced researchers
Our experienced teams can help your product development stay on track. We’ll put together an integrated team of experts to help you ask relevant research questions and gather the right data to build an informed strategy for regulatory approval and post-approval activities - giving you the best opportunity to obtain market entry for your product as quickly as possible after regulatory approval.
A Wealth of Experience
We have collaborated with our clients on projects to research a variety of cell and gene therapies. Our experience with these therapies includes several disease areas:
- Sickle cell disease
- Neuronal ceroid lipofuscinosis type 2 (CLN2) disease
- Duchenne muscular dystrophy
- Spinal muscular atrophy