Regulatory Solutions

Regulatory Information Management (RIM)

“Quality is never an accident. It is always the result of intelligent effort.”
- John Ruskin

Don’t let regulatory submissions keep you up at night

With nearly 20 years of experience in regulatory compliance, Calyx's industry-leading Regulatory Information Management (RIM) system will help ensure you meet regulatory requirements worldwide.

From complicated to compliant

Regulatory submissions can be complicated, time-consuming, and subject to non-compliance. Take the worry out of your submissions. And focus on getting new treatments to market.

Calyx RIM drives regulatory compliance by:

- Streamlining and optimizing your regulatory affairs processes
- Establishing comprehensive registration oversight
- Providing a single location from which to track your worldwide registrations

How? With submission planning, publishing, and registration management capabilities, Calyx RIM supports you throughout every stage of your regulatory journey.

Experience you can rely on

Calyx's RIM software is relied on by 18 of the world’s top 20 global pharmaceutical companies.

Reach out to learn how Calyx’s extensive experience and proven RIM system can pave the way to your program’s success.

Learn how Calyx RIM propels your regulatory submissions to success.

Calyx = submissions solved

Successful regulatory submissions require more than new technology. It’s essential to work with a provider who not only understands regulatory complexities, but who also brings together best of breed systems that meet your stakeholders’ needs.

Calyx pioneered the field of regulatory information management. Since the early 2000’s, over 20 million regulatory records have been seamlessly migrated into the Calyx RIM system, representing over 1 million global submissions to date.


The future of Calyx RIM is on Azure

Leverage the latest Azure-native technologies designed to improve regulatory efficiencies while ensuring patient safety.

Calyx RIM on Azure gives you the flexibility to choose the timing of your upgrade to ensure minimal system disruption. Through automated components and cutting-edge microservices, rapid upgrades are delivered directly  ̶  at a time that suits your business needs and schedule  ̶  so you gain access to new features while maintaining compliance with global regulatory requirements.

Benefits of Calyx RIM on Azure

– Accelerated return on investment through resource savings

– Optimized workflows to drive regulatory efficiencies

– Shortened release cycles

– Immediate availability of new capabilities

– The elimination of lengthy and expensive software upgrades

Your source for IDMP readiness

With the deadline for IDMP submissions on the horizon, it’s time to regroup and ensure your data is ready for submission. Will you be ready?

To help you prepare, we’ve amassed a variety of resources including articles, updates, and guides detailing how to overcome implementation challenges and what factors need to be considered to ensure your compliance with IDMP Iteration 1 submissions.


The MAH’s Guide to Preparing for IDMP

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Calyx RIM on Azure

Learn how Calyx RIM on Azure combines the power and capabilities of Microsoft’s scalable, flexible, and secure platform with Calyx’s expertise.
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Optimizing Regulatory Information Management

With an effective Regulatory Information Management (RIM) system, you can learn from your experiences, anticipate regulatory requests, and ultimately, get treatments approved faster to help improve people’s lives.
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Change the Way you Work with Calyx RIM for Office 365

Discover how Calyx RIM for Office 365 elevates productivity by utilizing machine learning to simplify everyday tasks.
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