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Compliance Intelligence
for Life Sciences

The AI Powered Platform for Regulatory Insights, Surveillance and Compliance

360° Compliance. In One Tool. 

Every regulation, safety measure, and global update in one tool. Hoodin equips RAQA teams with the intelligence and surveillance to meet compliance demands across the full lifecycle, whether you’re active in a few markets or expanding globally.

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Navigate Your Global Regulatory Landscape with Confidence

Streamline regulatory intelligence, get timely updates and actionable insights tailored to your products and markets.

Global Standards Compliance Made Simple

Stay compliant with global standards - effortlessly.

24/7 Compliance with 360° Post-Market Surveillance & Safety Updates

Stay ahead of safety concerns with continuous, real-time updates.

Future-Proof with Global Technology & Innovation Monitoring

Innovate and adapt across regions with confidence. 

Achieve 360° Compliance with Hoodin: No Surprises, Just Action.

Hoodin is your comprehensive solution for navigating the complexities of regulatory compliance in the life sciences. By constantly monitoring over 2,000 life science-specific sources for open data and over 600 regional and local regulations, you receive precisely what you need, when you need it.

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AI Support to Gain 360° Compliance for Your Product

  • Customised intelligence profiles for specific products

  • AI summarises regulatory updates with implications for your products

  • Supports decision-making with data-driven insights

 Smart Regulatory List – Create and Stay Updated on Your Applicable Regulations

  • Build a tailored, up-to-date list of applicable regulations, including EU regulations, directives, and local laws (currently focused on Europe).

  • Receive in-system alerts of new regulations, revisions, and amendments that impact your products.

  • Track changes in local and international compliance requirements with summarised key points for each regulation.

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Monitor Your Applicable Standards and What’s New

  • Automatic tracking of changes to relevant standards

  • Access harmonisation news and global standard updates

  • Identify which standards impact your product’s regulatory journey

Automated Product Surveillance

  • Real-time monitoring of literature, clinical trials, and trade mentions

  • Capture adverse event data for robust risk assessment

  • AI-powered translation and summarisation of complex literature, supporting safety evaluations and compliance

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A Look Into the Future

  • Get insights on new technologies, innovations, and patents specific to your product’s indication, intended use, materials/active ingredients, and markets

  • Monitor emerging trends and breakthroughs impacting your product’s lifecycle

  • Stay ahead with insights into the latest tech developments shaping the industry

Reporting & Collaboration for Actionable Compliance

  • Export and customise compliance reports for stakeholders

  • Facilitate teamwork with collaborative data sharing and commenting

  • Integrate Hoodin with your QMS for efficient tracking of regulatory actions and compliance-related tasks

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Regulatory Affairs Expert, Solutions for tomorrow

Elisabeth Lundahl

“We have used Hoodin for our clinical evaluation. It was convenient to have everything in one place. Since our product (X-ray) has been around for a long time, not much happens, but it's easy to create a report and have everything in the same place. One of the great things about using Hoodin is that you easily could start to monitor adjacent technology areas, such as software and cyber security without spending a huge amount of time to find the necessary sources, determining what you need to gather etc.
 
To me, one of the most important differences is that it feels safe with Hoodin because there is a clearer structure and you know that there is a process that is constantly running.”
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Frequently Asked Questions

How much does it cost?

Check out our price list here.

What products is Hoodin suitable for?

Hoodin is designed for a wide range of life sciences products, including medical devices, IVD, SaMD, Combination products, pharmaceuticals and biotechnology innovations.

Is there a trial period available?

Yes, we offer a free trial period of 14 days for new users to experience Hoodin’s capabilities firsthand before committing to a subscription.

How much time does it take to evaluate and try the tool?

We offer a streamlined onboarding process. You can expect to start seeing initial results within a few days of setting up your project. Expect to set aside 30 minutes to set up your first hub and then we recommend 2 time 30 minuts more to investigate the results and try out various features. We strongly recommend that every trial period shall include a video meeting with one of our experts to secure that you get the best out of Hoodin.

Ready to Elevate your Compliance Strategy

By choosing Hoodin, you’re not just investing in a tool; you’re gaining a partner committed to supporting your compliance journey and enhancing your organisational efficiency.

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