Image credits: Qdossier
Chicago-based Celegence, a provider of regulatory affairs services and solutions for life sciences companies, announced on Monday that it has acquired Waalwijk, the Netherlands-based Qdossier.
Qdossier helps life sciences organisations record and exchange proof of quality, safety, and efficacy of medicinal products.
Why this acquisition?
Celegence says that the acquisition will enable it to enhance its extensive network of regulatory consultants for the pharmaceutical industry with the addition of Qdossier’s regulatory experts.
The US company developed CAPTIS, EU Medical Device Regulation (MDR), and In-Vitro Diagnostic Regulation (IVDR) compliance technology to automate medical writing and document maintenance.
Adding Qdossier’s cloud-based dossier management solution Dossplorer, Celegence has widened the scope of its offering
Hans van Bruggen, CEO and Senior Regulatory Affairs Scientist at Qdossier, says, “This partnership enables us to further expand our global presence with complementary expertise and technologies. We will continue to help our customers realise greater efficiencies as they record and exchange proof of quality, safety, and efficacy of medicinal products.”
He adds, “We are delighted to join the Celegence team and work with them to deliver first-class customer service, as we support our customers to efficiently comply with complex regulations and successfully deliver products to patients.”
As a part of the acquisition, the joint organisation’s total number of employees increases to 150, with two new offices in the Netherlands and Romania.
Celegence: What you need to know
Founded by Punya Abbhi and Sonia Veluchamy, Celegence provides services and solutions to support the Life Sciences industry with regulatory affairs operations and strategy.
Celegence supports life science customers in the areas of EU MDR compliance, IVDR compliance, regulatory intelligence, RIMS data management, publishing, regulatory labelling, including UDI consulting, and medical writing.
Sonia Veluchamy, CEO of Celegence, says, “Qdossier’s regulatory expertise and technology complements our own portfolio of services and solutions. We work with our clients as trusted advisors with the aim of improving efficiency in regulatory compliance, helping them to successfully launch new products to market and maintain them.”
“The combination of Celegence and Qdossier’s expertise, coupled with technology that supports compliance and effective data and document management, will enable us to deliver hands-on, strategic, highly personalised regulatory support to pharmaceutical industries across the globe,” she adds.
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