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Cunesoft GmbH joins forces with Phlexglobal

The Munich-based Cunesoft GmbH, an innovative provider of cloud-based intelligent regulatory data management software and services for the life sciences industry, announced today that it has been acquired by Phlexglobal from all shareholders including current investors such as Bayern Kapital, High-Tech Gründerfonds and OCCIDENT.  

Phlexglobal, the leading provider of Trial Master File (TMF) software and expert services joins forces with Cunesoft, which expands the company’s portfolio of best-of-breed technologies designed to provide solutionspecific functionality to meet the business objectives of life sciences companies. Phlexglobal is backed by Vitruvian Partners, an international private equity firm headquartered in London backing high-growth companies. 

“The entire Cunesoft team is very excited about this new chapter in our story”, said Rainer Schwarz, Cunesoft co-founder and Chief Executive Officer. “Phlexglobal has a long history of providing expert services and leading software technology to its customers, and this will allow us to build on the work we have already done to advance and automate many of the processes crucial to the management of data for life-saving drugs and medical devices.” 

“We will be offering customers two levels of immediate benefits with this acquisition”, said Phlexglobal CEO John McNeill. “First, we will be providing a suite of solutions that will unify the relevant processes and data elements between the Clinical Operations and Regulatory departments of life sciences companies, combining our years of thought leadership in eTMF with Cunesoft’s expertise in regulatory matters. Second, and just as important, we will be leveraging Cunesoft’s Distiller solution to package that expertise into digitalized offerings to not only augment our own suite of solutions but to operate with any existing set of solutions that might already be in place.” 

Daniel Koppers, Cunesoft co-founder and CTO said: “I am very excited to combine our innovative regulatory software technologies with Phlexglobal’s eTMF solutions. ‘From trial to file’ is a great solution theme and our customers will love it.” 

Bayern Kapital and High-Tech Gründerfonds invested in Cunesoft during its seed round in 2014, OCCIDENT joined as lead investor during a series A round in 2016. All investors have accompanied the young company in its development from a promising software start-up to a valued partner for the international Life Sciences industry with a sophisticated software solution. 

Dr. Bernd Goergen, partner with High-Tech Gründerfonds who were invested into Cunesoft since 2014, comments: “Sometimes it seems hard to let a portfolio company go, but at the same time we are happy about having contributed for more than 5 years to the success story of Cunesoft. Moreover we share the founders’ excitement to even further accelerate the international growth of their unique software solutions for the regulated markets as a part of Phlexglobal.” 


Dr. Georg Ried, Managing Director of Bayern Kapital, says: “When we invested in Cunesoft during its seed round more than five years ago, we were convinced of its technology, its talented team and its market potential. We are delighted that Cunesoft proved itself when it comes to all these aspects and developed into a successful company with international reach and a convincing solution for a high-profile client base. We believe that with support from Phlexglobal, Cunesoft has found the right partner to reach the next level of its development.” 

 Cédric Barra, Investment Manager with OCCIDENT, adds: “As one of the investors, we are particularly pleased to have acted as an enabler for Cunesoft and are proud to have supported the digital progress of large-scale data management in the healthcare sector. We are happy to see Phlexglobal being the perfect partner for the founders and the further internationalization of Cunesoft’s unique solution. We congratulate on this great success.” 


Members of both the Phlexglobal and Cunesoft management team will be available to discuss their vision for the future of TMF and Regulatory management at the 9th Annual Trial Master File Summit in Orlando, Florida, from January 21st through 23rd, and the DIA Regulatory Submissions, Information, and Document Management Forum (RSIDM) in North Bethesda, Maryland, February 10th through 12th. 


About Cunesoft:  Cunesoft GmbH is a provider of intelligent regulatory software and services for all segments within the life sciences industry. Solutions include management of eCTD, xEVMPD, IDMP data and document management as well as regulatory information management (RIM). Automated data mining based on NLP and Deep Learning algorithms complement the product portfolio. Software provisioning is provided as Private Software as a Service (SaaS). The company is headquartered in Munich (Germany) with international offices in the UK, US and India. 

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Last Updated: 16-Jan-2020