dosyap Presents DOR
Smarter. Faster. Compliant
Meet DOR, dosyap’s AI-Powered Regulatory Robot.
DOR is an artificial intelligence powered automation that examines the reference file (EU), makes gap analysis and creates regulatory affairs files in specific language according to local regulations.
Our local RA specialists make quality checks to the files before delivery and feed our AI model to enhance its performance. By combining AI capabilities with local regulatory expertise, dosyap ensures that every file is compliant, consistent, and delivered at industry-leading speed.
dosyap’s AI-powered DOR system revolutionizes regulatory affairs.
The process starts with the input provided by pharmaceutical companies—such as the EU reference file, company template, local medicine name, and country-specific documents. Raboid AI System then takes over: it calculates costs, identifies documentation gaps, performs translations, adapts files to company templates, and generates dossiers fully compliant with local regulations. With OCR technology, every document is digitized and standardized for error-free processing.
The AI-generated draft is not the final step. Local regulatory specialists review every file, validate terminology, and conduct a detailed compliance check. Their expertise feeds the AI, ensuring continuous learning and smarter results over time. Once approved, companies receive both the EU Reference File and a fully compliant Final File adapted to local requirements
Manual Workload Reduced
Up to 80% less manual effort with AI-driven automation.
Transparency & Control
End-to-end 100% visibility with centralized tracking and audit-ready records.
Faster Submissions
4× faster file creation and review for accelerated time-to-market.
Global Regulatory Compliance
Consistent, globally aligned files adapted to local regulations.
About The Solutions
Reinventing Regulatory Affairs with AI
dosyap’s AI-powered automation, DOR, transforms the way regulatory affairs are managed. By combining speed, compliance, and human expertise, DOR eliminates complexity, reduces rejection risks, and delivers 4x faster submissions. With centralized management, advanced pre-submission checks, and continuous AI learning, DOR ensures every file is smarter, faster, and fully compliant—helping pharma companies bring innovations to patients much sooner.
Faster File Creation
With dosyap’s AI-powered robot DOR, regulatory files are created 4× faster (4 weeks vs. 16 weeks). This acceleration shortens time-to-market and helps pharma companies deliver innovation to patients much sooner.
Pre-Submission Check
DOR automatically reviews your dossiers before submission—checking size, readability, and formatting to meet Ministry standards. This reduces the risk of rejection or delay and gives you full confidence in your submissions.
Enhanced RA Compliance
Through advanced AI-driven checks, DOR ensures that every file is consistent, accurate, and always aligned with the latest regulations. Compliance is no longer a challenge but a guarantee.
Centralized Management
Manage complex, multi-country submissions from a single platform. dosyap provides end-to-end visibility, making it easier to track, monitor, and control all regulatory operations in one place.
Continuously Improving AI
Supervised by local RA specialists, DOR learns from every project. This powerful combination of human expertise and AI intelligence delivers smarter and more reliable results with each submission.
Localized Compliance Adaptation
DOR specializes in adapting global reference files to local requirements. By examining EU reference dossiers, performing gap analysis, and generating local-language submissions, it ensures faster, standardized compliance worldwide.
Your Trusted Partner in Regulatory Affairs
Discover how dosyap’s AI-powered solutions transform regulatory affairs. Let’s work together to simplify processes, accelerate compliance, and deliver reliable results worldwide.
What happens next?
We Schedule a call at your convenience
We do a discovery and consulting meting
We prepare a proposal