Dossier Development

Dossier Development
and Gap Analysis.

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.

Throughout the dossier creation process, we are your active partner, able to identify gaps in your documentation and propose the best solution.

From gap analysis to smarter regulatory planning.

From young ambitious biotechs to more established pharma brands, most life sciences organizations will at some point look to broaden their international reach as they identify new opportunities and/or reach saturation in their core markets.

Yet unless they have scoped the respective regulatory requirements for each new territory from the outset, and continue to track them over time, the process of preparing and applying for market authorisation in each additional country could be costly – threatening speed of access and profitability, certainly in the short term.

It’s in this context that it pays to perform an early regulatory gap analysis, identifying the additional or differing requirements of potential future markets – even if there are no immediate plans to take products into those additional countries. 

A guide to smarter regulatory planning, accounting for the additional needs of future target markets beyond the EU and US – from local clinical study requirements, launch strategies, and samples management, to differing expectations around legal document certification, and specific local requirements.

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