Qdossier is an established provider of end-to-end regulatory solutions and services, supporting a wide range of global business use cases in life sciences. The partnership with Generis will see Qdossier provide a comprehensive cloud-based content management offering which combines the latest tools, functionality and services to support anything companies need to do with regulatory data, documents and dossiers.

“We’ve had this vision for some time and have considered several software vendors and in Generis, we have found the right fit,” explains Hans van Bruggen, Qdossier’s founder and CEO.

“A major shift has taken place, which we are primed to address. Pharma companies no longer want to own multiple separate software systems that each fit a particular need. They need a solution that lets them focus on their core business while outsourcing IT administration related to installation, configuration, validation of systems and business administration of data governance, document publishing and dossier compilation.”

The combined, hosted offering from Qdossier, which the company expects to launch in the course of 2021, will comprise Generis’s CARA RIM and document management platform; Qdossier’s Dossplorer™ dossier / eCTD viewer and Dosscriber™eCTD templates; and an eCTDbuilder solution; along with Qdossier’s regulatory expertise and wraparound services. These include the Qdossier Best Practice configuration of CARA for a range of regulatory, chemical, pharmaceutical, clinical and non-clinical use cases.

“Collaborating with Generis has been an easy and logical decision, because there is so much synergy: our respective strengths complement each other perfectly,” Hans says. “CARA gives us a powerful engine to build out our end-to-end cloud proposition, which will drive new services business for Qdossier, while Generis will expand its licence revenue with relatively low touch.

“With our combined proposition, we will unburden customers of the need to implement and maintain systems. As well as multi-tenant hosting, we are bringing best practice and a complete set of services, including the admin people to manage all the data,” Hans adds. “We can add and configure the relevant controlled vocabularies for different markets and accelerate document and dossier production by linking particular dossier layouts with the correct information.”

The combined Qdossier offering will come into its own as small and mid-sized companies in particular grapple with new Brexit-related requirements, and as European markets move closer to ISO IDMP adoption, Hans notes.

“We’re filling a gap in the market and removing the pain from organisations that have enough on their plate,” he continues. “Smaller companies won’t have to search for the right combination of capabilities, and larger companies with complex IT estates will be able to streamline their content and dossier management activities on a single, common, pre-configured and optimised platform.”

Commenting on Qdossier’s decision to standardise on CARA, James Kelleher, CEO at Generis, said, “We are delighted that Hans and the team at Qdossier have selected Generis to underpin this new cloud-based service offering. It’s becoming a no-brainer for life sciences organisations to consolidate and modernise their regulatory and other content management activities, as requirements expand and speed to market becomes ever more critical.

“Our SaaS platform supports intelligent content services across RIM, Regulatory/R&D, Safety, Clinical, Non-clinical, Quality GxP, CMC, Pharmacovigilance, Medical Information /Medical Affairs use cases and more. It enables easy information flow across the enterprise, streamlining processes and reducing costs. Relevant teams can see what has been approved, and where, at a glance; what affiliates have done locally; and the plans and status of all ongoing regulatory work – all within a few easy clicks.”

About Generis

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’ flagship Intelligent Content Services 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

About Qdossier

Qdossier realizes efficient recording and exchange of the proof of quality, safety and efficacy of medicinal products since 2006.

Qdossier offers consultancy, services and solutions. Consultancy includes regulatory affairs all-round support and process development and solution implementation. Services include data, document and dossier management. Our solutions are DossplorerTM, a dossier / eCTD viewer; DosscriberTM, CTD document templates; and DossignerTM, a tool to design eDMS configuration and dossier outlines.

More at www.qdossier.com

Press Contact for Generis

Carina Birt, Sarum PR

+44 7970 006624