AI-powered dossier intelligence.
For faster, lower-risk regulatory and in-licensing decisions for the pharmaceutical industry.
VALUE PROPOSITION
What Does Dossiate Do?
Dossiate reduces the time, cost, and risk of manual dossier review by using AI to analyse regulatory documents, identify gaps, and support submission readiness and in-licensing strategy across global territories.
THE CURRENT PROBLEM
Manual, time-consuming and resource intensive.
Regulatory dossier review and in-licensing due diligence in the pharmaceutical industry are highly manual, time-consuming, and resource-intensive processes. Companies often require multiple regulatory experts to assess large volumes of documentation over several weeks, or in some cases in very short time-frames, increasing costs and the risk of missed gaps or inconsistencies.
This can lead to regulatory delays, Requests for Further Information (RFIs), failed submissions and, ultimately, lost market opportunities. Smaller and mid-sized companies are particularly affected, as they often lack access to large enterprise systems and rely heavily on spreadsheets, checklists, and external consultants.
OUR SOLUTION
An intelligent, AI-enabled regulatory platform.
Analysis
Dossiate analyses regulatory dossiers and supporting documentation to identify missing information, inconsistencies, and potential risks.
Automation
Automating key aspects of dossier gap analysis and due diligence significantly reduces manual workload, shortens review timelines, and supports more consistent and data-driven regulatory decision-making.
Feedback & Trends
Over time, the system integrates anonymised feedback and trends to enhance predictive insights, enabling companies to improve submission quality, reduce RFIs, and optimise lifecycle regulatory strategies across multiple territories.
Who is it for?
Marketing Authorisation Holders, Pharmaceutical in-licensing and Business Development teams, Regulatory Consultancies, CDMOs supporting regulatory submissions, Regulatory Affairs Professionals.
TALK TO US
Get in touch.
If you are interested in hearing more about the Dossiate platform or have any questions, please get in touch as we would love to speak with you.