AI for REGULATORY AFFAIRS
A modern tool supporting Regulatory Affairs teams in their day‑to‑day work. We automate processes, organize data, and accelerate regulatory activities.
Documentation automation
We streamline the creation, analysis, and review of regulatory documents, reducing time and minimizing the risk of errors.
Faster and more accurate decisions
We deliver structured information and insights that genuinely support decision‑making by RA teams.
What is REGULATORY REVOLUTION?
Regulatory Revolution is an AI‑powered application designed specifically for Regulatory Affairs teams. It combines regulatory expertise, automation, and intelligent data processing to simplify even the most complex regulatory processes.
What do you gain?
reduced risk of errors
better control over data
PROBLEMS WE SOLVE
Time‑consuming analysis of CTD documents
Manual comparison of document versions
Lack of consistency in regulatory data
Fragmented information sources
Risk of human error
Limited process transparency
Aplikacja pozwala na niezależną i obiektywną ocenę ryzyka przy due diligence.
Excessive workload for RA teams
Challenges in managing regulatory changes
Faster and more accurate than traditional methods
Key features of our application
Intelligent analysis of regulatory documents
The system analyzes all CTD modules against guidelines, detecting gaps, inconsistencies and areas that are inconsistent with regulatory guidelines.
Automatic version comparison
The application compares different versions of documents or dossiers provided by partners, automatically identifying differences and risks.
Information search within CTD documents
The tool takes into account local requirements (EU, USA, Middle East, Asia, Africa).
Support for regulatory compliance assessment
The user receives a clear report indicating errors, missing elements, proposed corrections and a regulatory risk assessment.
Centralized knowledge repository
The application speeds up the analysis of documentation before purchasing a dossier – shortening the audit from weeks to hours/days.
Tools supporting team collaboration
The application speeds up the analysis of documentation before purchasing a dossier – shortening the audit from weeks to hours/days.
Our mission
Our mission is to revolutionize the work of Regulatory Affairs teams through the use of artificial intelligence. We aim to simplify complex regulatory processes, increase team efficiency, and enable teams to focus on activities that deliver the highest value.
Questions and answers
Who is Regulatory Revolution for?
For Regulatory Affairs teams in pharmaceutical, biotech, and medtech companies.
Is the application compliant with regulatory requirements?
Yes, it is designed with compliance and data security in mind.
Can the solution be tailored to an organization’s needs?
Yes, the application is scalable and flexible.
Contact us
Would you like to learn more or see a demo?
Get in touch with us and let’s discuss your regulatory needs.
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Regulatory Revolution Sp. z o.o.
ul. Stanisława Moniuszki 11
35-015, Rzeszów
POLAND
REGON: 543535309
NIP: 8133944483