Quality Overall Summary is a regulatory document that contains an overview of all quality-related information provided by marketing authorization applicants to regulatory authorities. The summary is intended to facilitate the review of the critical quality information and decrease the effort needed by regulators to understand and interpret quality-related data in an application.

Biomapas internal and external experts can support you in preparing Quality Overall Summary making sure it promotes effective communication and is harmonized with the module 3 of your eCTD document.