Specialist regulatory consultancy
Taking cell and gene therapies into markets beyond the US and EU, from first filing to the first treated patient.
We work alongside your global regulatory team to take approved advanced therapies and innovative medicines into the Middle East, Africa and other markets your central team does not cover yet.
Founder track record
What we do
Advanced therapies
Dossier due diligence, reliance-based filing, pricing, treatment centre activation and risk management for CAR-T and other cell and gene therapies.
Learn moreSpecialty and innovative medicines
Market assessment, registration, pricing and partner selection for companies with an approved product and no presence in the region. We do not take on generics.
Learn morePortfolio transactions
Licence transfers, acquisitions and divestments across many markets, planned so the product stays on the shelf.
Learn moreHow we work
We take on a small number of projects at a time, as a fixed-scope project, a retainer through launch, or expert input on a specific question, and we are happy to work as named associates through your consultancy or network.