Regulatory Solutions

Regulatory Information Management (RIM)

Calyx RIM is a proven, cloud-based regulatory information system for optimizing regulatory publishing, submissions, and registrations.

Regulatory Solutions

Regulatory Information Management (RIM)

Calyx RIM is a proven, cloud-based regulatory information system for optimizing regulatory publishing, submissions, and registrations.

Streamline and optimize your regulatory affairs processes.

Uniquely combining innovative cloud technology with decades of regulatory and user experience, Calyx delivers a scalable and flexible RIM solution that addresses the full complexity of today’s regulatory environment.

Designed by regulatory experts and proven across over 1 million global submissions to date, Calyx RIM is a regulatory solution you can rely on.

 

Streamline and optimize your regulatory affairs processes.

Uniquely combining innovative cloud technology with decades of regulatory and user experience, Calyx delivers a scalable and flexible RIM solution that addresses the full complexity of today’s regulatory environment.

Designed by regulatory experts and proven across over 1 million global submissions to date, Calyx RIM is a regulatory solution you can rely on.

 

Easing the burden of compliance.

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

Registrations

Calyx RIM gives users confidence in their ability to centrally plan, manage, and track product information, registrations, and authorizations throughout the life of each product.  Built specifically to drive regulatory compliance, Calyx RIM streamlines regulatory affairs processes, giving users comprehensive oversight of product registration portfolios in a single location.

The market-leading RIM solution, Calyx RIM increases global coordination and collaboration between departments and affiliates by sharing a common authoritative information source and enabling users to manage projects that span multiple applications.

With IDMP standards incorporated directly into Calyx RIM, pharmaceutical companies absorb the IDMP data as part of their daily processes, ensuring compliance with emerging requirements.

Submission Publishing

Calyx RIM provides comprehensive and scalable submission publishing solutions that are suitable for operations of all sizes and produce output that is compliant with regulatory agency requirements.

It has easy-to-use submission assembly controls with components designed specifically for the capture and management of eCTD metadata. Submission assembly templates are provided and maintained by Calyx for both eCTD and non-eCTD formats. Workflow capabilities support users through multiple activities, with dependencies and defined pre-set fields that guide processes within the system.

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

Easing the burden of compliance.

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

Registrations

Calyx RIM gives users confidence in their ability to centrally plan, manage, and track product information, registrations, and authorizations throughout the life of each product.  Built specifically to drive regulatory compliance, Calyx RIM streamlines regulatory affairs processes, giving users comprehensive oversight of product registration portfolios in a single location.

The market-leading RIM solution, Calyx RIM increases global coordination and collaboration between departments and affiliates by sharing a common authoritative information source and enabling users to manage projects that span multiple applications.

With IDMP standards incorporated directly into Calyx RIM, pharmaceutical companies absorb the IDMP data as part of their daily processes, ensuring compliance with emerging requirements.

Submission Publishing

Calyx RIM provides comprehensive and scalable submission publishing solutions that are suitable for operations of all sizes and produce output that is compliant with regulatory agency requirements.

It has easy-to-use submission assembly controls with components designed specifically for the capture and management of eCTD metadata. Submission assembly templates are provided and maintained by Calyx for both eCTD and non-eCTD formats. Workflow capabilities support users through multiple activities, with dependencies and defined pre-set fields that guide processes within the system.

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

Experience you can rely on.

Calyx delivers not only the advanced technology, but also the expertise of our people and proven processes that have helped worldwide pharmaceutical companies streamline regulatory affairs processes time and time again.

Experience you can rely on.

Calyx delivers not only the advanced technology, but also the expertise of our people and proven processes that have helped worldwide pharmaceutical companies streamline regulatory affairs processes time and time again.

15+
YEARS
1M+
GLOBAL
SUBMISSIONS
15+
YEARS
1M+
GLOBAL
SUBMISSIONS
20M+
REGULATORY
RECORDS
18
OF THE WORLD’S TOP 20
PHARMACEUTICAL COMPANIES
20M+
REGULATORY
RECORDS
18
OF THE WORLD’S
TOP 20
PHARMACEUTICAL
COMPANIES

Helping you stay future-ready.

Just as regulatory compliance is a fact of life in our industry, so too is constant change in regulatory requirements. Rely on Calyx RIM to keep you up-date.

regulatory information management system benefits

IDMP – Confidence in Compliance

Strong, controlled regulatory information is key to IDMP. Equally important is the careful planning and coordination that must take place across many internal functions and external partners in order to adopt these standards.

With nearly 100 collective years’ experience in regulatory operations and compliance, trust Calyx regulatory consulting to give you confidence in your IDMP preparation and compliance strategy.

regulatory information management system benefits

Evolving Standards

Future health authority requirements will focus on structured data reporting. Life sciences companies need to focus their attention on this key area. It’s essential to work with a regulatory information management system that’s built on an understanding of regulatory complexities and is continually updated to reflect the evolving worldwide regulatory arena.

Rely on Calyx RIM to steer you through the evolving requirements that will impact your regulatory publishing processes, allowing you to concentrate on getting drugs to market.

regulatory information management system benefits

Automations and efficiencies

Calyx RIM leverages Microsoft’s Azure-native, cloud technology to improve regulatory efficiencies while ensuring patient safety. Through automated components and cutting-edge microservices, rapid upgrades are delivered directly to your environment, giving you confidence in your regulatory compliance at all times.

And Calyx RIM streamlines the time it takes to do common activities; removing mundane tasks and allowing your experts to focus on improving patients’ lives.

Regulatory Information Management System Experts

With a depth and breadth of regulatory experience unmatched in the industry, Calyx’s Regulatory Consultants are routinely trusted by worldwide pharmaceutical companies for support in maneuvering the nuances of the global regulatory landscape.

Rely on our team to help you optimize regulatory processes, meet constantly evolving requirements critical to maintaining product registrations, and keep your products on the market for patients around the world.

Regulatory Information Management System Experts

With a depth and breadth of regulatory experience unmatched in the industry, Calyx’s Regulatory Consultants are routinely trusted by worldwide pharmaceutical companies for support in maneuvering the nuances of the global regulatory landscape.

Rely on our team to help you optimize regulatory processes, meet constantly evolving requirements critical to maintaining product registrations, and keep your products on the market for patients around the world.

Library

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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