Your dossier – the key to success.
Successful applications start with an accurate, compliant, and smart dossier and Arriello offers full ‘hands on’ support with creating your complete EEA, dossier, starting right from the raw manufacturing and expert data.
Through the extensive use of our regulatory intelligence, we ensure fully compliant content, using experience, analysis of precedents and new regulatory tools to create smart dossiers. We know this proven approach contributes to faster approvals, and reduces the number of changes with regulatory impact, throughout your product’s life cycle.
Our experts have extensive backgrounds in manufacturing and clinical environments, which also makes them excellent regulatory writers. And we always consider the integration of authority feedback to improve dossier content and reduce the number of deficiency letters.
We know from experience that collaboration between MAHs and manufacturers is also critical to ensure that the presented dossier information is both correct and supports each section efficiently.