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AI-Driven Solution for Faster, More Compliant Regulatory Submissions

Document Intelligence

Main challenge

An emerging pharmaceutical company faced recurring delays and documentation errors during the preparation of regulatory submission packages.

Despite having a capable team of medical writers and regulatory consultants, and using an eCTD-compliant submission system, the company encountered issues such as:

Missing or duplicated information
Inconsistencies across reports
Lack of synchronisation within the team

In addition, they lacked the financial resources and IT infrastructure to implement a full-scale enterprise solution. The manual effort required to extract and organise relevant content from complex clinical and CMC documents proved inefficient, error-prone, and unsustainable for their scale.

Med Dossier

The Winning Formula

We introduced MedDossier, a modular AI-powered tool designed to support specific tasks within the regulatory submission workflow — offering a more cost-effective and easier-to-implement alternative to enterprise systems.

MedDossier operates on the following principles:

It recognises the formal structure and regulatory requirements for each report
It extracts relevant data from multiple sources, even when presented in varied formats (e.g. tables, diagrams, narrative text)
It flags missing, inconsistent, or duplicated content according to the target structure

MedDossier includes features such as:

Content extraction from large, complex source documents
Structure mapping aligned with FDA and EMA requirements
Gap analysis and duplication detection
Generates submission package for review

The extracted content is prepared and structured in a way that makes it ready for expert review, ensuring accuracy without removing human oversight.

Achievements

12× faster submission preparation
MedDossier reduced the time needed to compile, structure, and validate reports for regulatory authorities.
75% fewer submission rejections
The tool’s intelligent validation engine minimized critical errors, leading to smoother reviews and significantly fewer regulatory pushbacks.
67% shorter quality control cycles and fewer man-hours
It streamlined quality control workflows, reducing manual workload and freeing teams to focus on higher-value activities.
90% fewer formatting errors
Consistent document structure and clean formatting lowered the risk of compliance issues and minimized rework.
Task-specific deployment
As a modular tool, MedDossier was used for targeted tasks in the regulatory process — allowing the client to benefit from focused automation without the cost or complexity of an enterprise system.

Takeaways

MedDossier enabled the client to improve submission speed and accuracy without overhauling their infrastructure.
Its modular design made it ideal for mid-size organisations needing targeted automation within specific regulatory tasks.
Human experts remained in the loop, reviewing content that had already been extracted, validated, and aligned with compliance standards.
Its flexible modular design ensured that the client could tailor the solution to their needs, enhancing efficiency and compliance across various regulatory landscapes.