Marielle Fournier PharmD

Marielle specializes in Quality regulations, such as ISO 9001 / ISO 13485 and EU GMP regulations, and has good knowledge on QSR (21 CFR part 820). She assists in the identification, development and implementation of Quality Systems appropriate to the need, complexity and size of an organization.

As Senior Director, Marielle has several responsibilities within the management of projects involving the design and implementation of global regulatory strategies for the development, evaluation and marketing of medical devices & medicinal products, as well as combination products (i.e. drug/device, including combined ATMPs) and borderline products. She actively participates to the redaction and review of ATMPs and Combined ATMPs US/EU dossiers. She closely follows the evolution of new regulations.