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Picture credit: Qdossier
Chicago-based Celegence, a supplier of regulatory affairs companies and options for all times sciences corporations, introduced on Monday that it has acquired Waalwijk, the Netherlands-based Qdossier.
Qdossier helps life sciences organisations file and change proof of high quality, security, and efficacy of medicinal merchandise.
Why this acquisition?
Celegence says that the acquisition will allow it to boost its in depth community of regulatory consultants for the pharmaceutical trade with the addition of Qdossier’s regulatory specialists.
The US firm developed CAPTIS, EU Medical Gadget Regulation (MDR), and In-Vitro Diagnostic Regulation (IVDR) compliance know-how to automate medical writing and doc upkeep.
Including Qdossier’s cloud-based file administration answer Dossplorer, Celegence has widened the scope of its providing
Hans van Bruggen, CEO and Senior Regulatory Affairs Scientist at Qdossier, says, “This partnership permits us to additional broaden our world presence with complementary experience and applied sciences. We’ll proceed to assist our clients realise higher efficiencies as they file and change proof of high quality, security, and efficacy of medicinal merchandise.”
He provides, “We’re delighted to affix the Celegence group and work with them to ship first-class customer support, as we assist our clients to effectively adjust to complicated laws and efficiently ship merchandise to sufferers.”
As part of the acquisition, the joint organisation’s whole variety of staff will increase to 150, with two new workplaces within the Netherlands and Romania.
Celegence: What it’s essential know
Based by Punya Abbhi and Sonia Veluchamy, Celegence gives companies and options to assist the Life Sciences trade with regulatory affairs operations and technique.
Celegence helps life science clients within the areas of EU MDR compliance, IVDR compliance, regulatory intelligence, RIMS information administration, publishing, regulatory labelling, together with UDI consulting, and medical writing.
Sonia Veluchamy, CEO of Celegence, says, “Qdossier’s regulatory experience and know-how enhances our personal portfolio of companies and options. We work with our shoppers as trusted advisors with the goal of enhancing effectivity in regulatory compliance, serving to them to efficiently launch new merchandise to market and keep them.”
“The mixture of Celegence and Qdossier’s experience, coupled with know-how that helps compliance and efficient information and doc administration, will allow us to ship hands-on, strategic, extremely personalised regulatory assist to pharmaceutical industries throughout the globe,” she provides.
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