- 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
Text mining for drug approval documents
DISQOVER's integrated and harmonized data outputs can easily be fed into AI/ML algorithms.
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
Text mining for drug approval documents
DISQOVER's integrated and harmonized data outputs can easily be fed into AI/ML algorithms.
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.
DISQOVER for Regulatory and NLP
Quickly find EMA or FDA referentials that are mentioned within drug approval documents, removing the need to manually search across large volumes of documents.
With DISQOVER enhanced with NLP functionality, users can extract valuable insights and knowledge from both structured and unstructured text data.
Key benefits of DISQOVER's NLP functionality:
Process private and public data with pre-configured yet adjustable annotators
One-stop-shop: one single solution for structured AND unstructured data
Modular and flexible: deploy NLP for a single use case or for multiple use cases at once
Expert team of data scientists, machine learning engineers, and bio-informaticians available to support with implementation and user roll-out
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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