- Keep up with the ever-evolving standards as set by the FDA, EMA, etc.
Accelerate submission timelines & success
- Reduce the time-consuming and complex submission and approval processes
- Deal swiftly with unexpected regulatory requests
Optimize regulatory processes
- Enhance cross-functional collaboration and knowledge sharing
- Streamline the regulatory submission process by providing easy access to all relevant information through one single platform
Manage and de-risk compliance
- Identify gaps in data
- Quickly respond to clarification requests by regulatory body
- Comply with drug shortage notification requirements by countries and regulators
Applications
Pre-Market Insights
DISQOVER's Pre-Market application enables regulatory affairs professionals access to comprehensive data to inform strategic decisions and optimize the success of product launches and market entry.
What can be accomplished in the Pre-Market Insights application?
Understand historical market trends, based on actual approval landscape competitor activities.
Establish an ontology-backed knowledge graph to drive regulatory insights and wider organizational efficiencies
Simplify post-authorization variations processes and drive further insights.
Address country-specific requirements.
Get an overview on safety, CMC, and label changes.
Key features
Advanced filteringand search
Export and comparedata
Integrated public andprivate data
Tailored dashboards
Alerts if new resultswith same criteriaappears
Medical Affairs
With DISQOVER's Medical Affairs application, medical affairs professionals and other relevant profiles canefficiently access the necessary data to support them in various activities, such as scientific communication, evidence generation, drug shortage reporting, and strategic decision-making.
What can be accomplished in DISQOVER?
Explore internal datato support your medical affairs strategy and activities.
Stay updatedthanks to access to a vast amount of scientific literatureand research publications, adverse events.
Examine regulatory informationby having access to regulatory databases and guidelines.
Review and compare labelling information.
Key features
Advanced filteringand search
Keep up with trends
Export and comparedata
Integrated publicand private data
Demo video
How to use DISQOVER for IDMP submission
Learn how the DISQOVER platform can help you and your team in finding the information you need for IDMP submission.
Leaflet
Stay on top of regulations, comply swiftly, and avoid costly mistakes
With DISQOVER for Regulatory, part of ONTOFOCE's intuitive knowledge discovery platform, unlock the power of linked data to efficiently drive regulatory, compliance and medical affairs processes.
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