Why DISQOVER for Regulatory?


Increase safety & ​transparency

- Address safety concerns

- Enable a view on the life cycle of a substance

- 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


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. 
  • Support product labelling assignment, review existing labelling, search amongst recommended nominations. 
  • 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 filtering and search
  • Export and compare data
  • Integrated public and private data
  • Tailored dashboards
  • Alerts if new results with same criteria appears
  • 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 can efficiently 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 data to support your medical affairs strategy and activities.
  • Stay updated thanks to access to a vast amount of scientific literature and research publications, adverse events.
  • Examine regulatory information by having access to regulatory databases and guidelines.
  • Review and compare labelling information.
Market assessment _ Product labelling _ Identifying KOLs _ Regulatory landscape analysis _ Strategic decision-making

Key features

  • Advanced filtering and search
  • Keep up with trends
  • Export and compare data
  • Integrated public and 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
ONTOFORCE DISQOVER Natural Language Processing (NLP) platform image


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. 

Disqover for Regulatory


Start your data and knowledge management journey today

Request a demo