Augmented Regulatory Intelligence at your Fingertips.

Our platform helps you leverage past regulatory data to find evidence-backed answers to your most complex questions.

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Reconstruct development timelines

Quickly piece together the detailed development timelines of relevant products without having to sift through thousands of documents. Visualize the studies that were submitted and the events leading up to regulatory decisions.

Learn from the precedents

The impracticality of sifting through an abundance of scientific knowledge means there's a huge amount of redundancy in drug research and development. Utilizing our platform means you can learn from past development strategies and leverage the work of your peers, including their wins and mistakes.

Learn from the precedents

The impracticality of sifting through an abundance of scientific knowledge means there's a huge amount of redundancy in drug research and development. Utilizing our platform means you can learn from past development strategies and leverage the work of your peers, including their wins and mistakes, not just your own.

Fill intelligence gaps

Many questions on past approvals remain unanswered due to their complexity. The information in the regulatory databases is disconnected, making it impossible to see the full picture. Our technology helps answer the most complex questions to equip you with all the details you need to make a decision.

Stay up to date on topics of interest

The information critical to your decisions is hidden in an overload of alerts and newsletters. Regulatory intelligence teams rely on our platform to detect and monitor key topics of interest wherever they arise across the regulatory knowledge bases.

Stay up to dates on topics of interest

The information critical to your decisions is hidden in an overload of alerts and newsletters. Regulatory intelligence teams rely on our platform to detect and monitor key topics of interest wherever they arise across the regulatory knowledge bases.

Conduct the most comprehensive regulatory research on any topic of interest. Simply enter your keyword and apply any relevant filters including date ranges, document sections, products, medical conditions, biomarkers, and regulatory designations.

Review documents side by side and automatically highlight differences and similarities.

Set alerts to stay up to date on the specific topics of interest. Opt to receive notifications when changes are made to regulatory databases to ensure you stay up to date.

Annotate and extract data points of interest directly from the documents. Leverage search logs, tags, highlights, and more to organize information in your own way.

Visualize your findings and segment them based on any criteria of interest. Apply page filters such as platform trials or real-world evidence to quickly zoom in on the topic of interest.

Create document collections and invite team members to work with you on a project. Data capture and analytics can be easily shared, allowing for seamless collaboration with others within your organization.

REMS for products with hepatotoxicity boxed warning

Using our platform, a regulatory intelligence team was able to search the boxed warning sections of all product labels to discover products with a hepatotoxicity warning. All documents associated with these products were then searched for examples of approved Risk Evaluation and Mitigation Strategies (REMS) implemented to manage these risks.

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Identifying trials supporting approvals for DLBCL

Not all Diffuse Large B Cell Lymphoma (DLBCL) studies listed in a clinical trial registry supported regulatory decisions. A few clicks on our platform revealed which regulatory-reviewed studies support approvals.

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Regulator feedback on the immunogenicity risk assessment of monoclonal antibodies

Using the right approach to assess the immunogenicity risk of monoclonal antibodies is important, with past regulator feedback a key consideration. Our platform was used to quickly pinpoint interactions with- and feedback from the regulators on the topic from the review packages of approved monoclonal antibodies.

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How often is your team asking regulatory precedent questions that are too complex to answer?

Below are examples of questions answered on our platform and how long each took:

Which products relied on Real World Data to support their approval?15 min

What were the areas of concern for regulators in the approval of cell therapy products?30 min

Which primary endpoints supported recent approvals in triple-negative breast cancer?10 min

Which products were recommended for Project Orbis?25 min

Get Started Today

Schedule a demo to find out how our platform helps augment your regulatory research and monitoring activities!

Schedule a Demo