Under the agreement, EXTEDO will become a leading Build Partner for Generis, leveraging the low-code flexibility of CARA, in combination with its own strong industry expertise, to develop new platforms for content, data and business process management.
EXTEDO, which has 25 years of Life Sciences industry experience, will harness CARA to rapidly expand its highly-regarded submission management and publishing solutions, enhancing its popular EXTEDOpulse RIM platform in line with its vision for the industry. This includes offering organisations an adaptable, comprehensive, end-to-end solution to their regulatory challenges.
More than 850 organisations and around 80% of the eCTD accepting regulatory agencies globally use EXTEDO solutions or services today. Many of the company’s experts, well known for their regulatory expertise, play leading roles within local standards committees, the ISO Group and national competent authorities, helping to define standards worldwide.
Commenting on the decision to select CARA™, Martin Schmid, EXTEDO’s CEO, said, “The potential is significant. CARA’s appeal is its flexibility and ability to integrate with other solutions, which fits with our desire to offer customers an adaptable, comprehensive, end-to-end solution to their regulatory challenges. It can be deployed on premise or via the cloud too, adding to its flexibility.”
EXTEDO has ambitions to expand into other regulated markets through the partnership. In addition to being a leader in Life Sciences, providing systems to eight of the 10 largest pharmaceutical companies, Generis has strong traction in engineering, utilities and energy, government and financial services.
“As well as being widely respected in Life Sciences, Generis has a lot of wider experience of simplifying information management complexity across other regulated and process-driven industries, knowledge which has enriched CARA’s functionality,” Martin noted, adding that he anticipates significant scope for joint development.
“Generis and the CARA platform are highly innovative, and we’re excited about futureproofing our offering with new AI-based capabilities, for example,” Martin said. “That could be in content recognition or in devising new and better ways of managing medicine or other product data.”
Generis has welcomed the relationship with EXTEDO and will support the company with the enhancement to EXTEDOpulse.
“It’s fantastic to have EXTEDO as a Build Partner,” commented James Kelleher, CEO of Generis. “We’re working as an extended team to help realise the extensions to the EXTEDOpulse platform, and we’re very pleased that EXTEDO has decided to leverage the power of CARA as a foundational platform to build these rich solutions.
“EXTEDO is a really respected leader in its field,” he added. “To provide a backbone to support its continuous innovation in the market going forwards, and to realise new visions for regulatory information management, is good for the industry as a whole.”
Generis is a UK-headquartered developer of world-class Content and Regulatory Information Management technology for regulated industries globally.
Eight of the top 10 global life sciences companies rely on Generis’s foundational platform, CARA™ for critical document and information management, including AbbVie, AstraZeneca, Biogen, Gilead, Bayer, Pfizer, and Merck KGaA.
Today Generis serves more than half a million users worldwide, across use cases ranging from RIM, Regulatory / R&D and Safety use cases to Clinical, Non-clinical, Quality GxP, CMC, Pharmacovigilance, Medical Information / Medical Affairs applications and more. More at generiscorp.com
EXTEDO is a leading solutions and services provider in the field of Regulatory Information Management (RIM). We focus on optimizing our clients’ eRegulatory business processes and provide solutions covering the entire regulatory landscape: Planning & Tracking, Document Management, Product Registration, Submission Management and Safety Management.
EXTEDO’s product portfolio EXTEDOpulse combines innovation with compliance and quality with usability.
Today, EXTEDO enables approximately 80% of the eCTD accepting regulatory authorities and 850 maintained customers across 60 countries to deliver Effortless Compliance™.
For more information visit www.extedo.com.
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