Scientific Advice

Advice given by a regulatory/ reimbursement authority to a manufacturer on appropriate tests and studies to be performed during product development/ application for product reimbursement, in order to avoid major objections being raised during evaluation of the marketing authorisation application/ reimbursement application.

Regulatory Strategy & Submissions

Design and implementation of global patient-centric regulatory strategies to ensure expedited product…

Cell, Gene and Tissue Therapies

Gene therapy, somatic or stem cell therapy and tissue engineering are at…