Regulatory Strategy for NCEs, Biologics, ATMPs

The registration of a medicinal (drug) product has become a complex project.

Especially within the European Union (EU) / European Economic Area (EEA), where different application procedures (centralized, mutual recognition / decentralized and purely national procedures) and different application types (e.g. hybrid, generic, well-established use, similar biological) need to be considered, the correct selection of a product-specific submission strategy turns into a challenge.

PhACT supports its clients with developing project-specific regulatory strategies for pre- and post-approval submission projects and assesses the most suitable route for submission.