Celegence acquires Qdossier to bolster its regulatory consultancy services and solutions for the pharmaceutical industry

Chicago, IL, 2022 - Celegence, a global provider of regulatory affairs services and solutions for the life sciences industry, has today announced the acquisition of Qdossier, a supplier of end-to-end services to support document and dossier lifecycle management for pharmaceutical products. Qdossier also provides leading cloud-based technology, which creates transparency, consistency, and reusability across regulatory dossiers.

This acquisition will see Celegence enhance its extensive network of regulatory consultants for the pharmaceutical industry with the addition of Qdossier’s regulatory experts. Together, they will continue to advise manufacturers on complying with regulatory requirements to launch and maintain products on the market.

In addition to providing consultative services, Celegence also developed CAPTIS™,  EU Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR) compliance technology to enable the automation of medical writing and document maintenance. With the addition of Dossplorer™, Qdossier’s advanced cloud-based dossier management solution, Celegence has widened the scope of technology offerings that can now benefit the industry.

Sonia Veluchamy, CEO at Celegence stated: “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 personalized regulatory support to pharmaceutical industries across the globe.”

Partnering with Celegence will see the joint organization’s total number of employees increase to 150, with the addition of two offices in the Netherlands and Romania. Celegence currently has offices in Chicago, London, and Bangalore.

Hans van Bruggen, CEO and Senior Regulatory Affairs Scientist at Qdossier said: “This partnership enables us to further expand our global presence with complementary expertise and technologies. We will continue to help our customers realize greater efficiencies as they record and exchange proof of quality, safety, and efficacy of medicinal products.” 

“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.”

About Celegence

Celegence helps life sciences companies navigate complex global regulatory requirements by providing consulting services and solutions dedicated to regulatory affairs. Celegence supports life science customers in the areas of EU MDR compliance, IVDR compliance, regulatory intelligence,  RIMS data management, publishing,  regulatory labeling including  UDI consulting, and medical writing. Celegence's depth of experience and extensive delivery capabilities allow regulatory affairs and quality teams to operate more efficiently, reduce cost, and improve compliance. For more information, visit www.celegence.com or follow Celegence on LinkedIn.      

About Qdossier

Qdossier helps life sciences organizations record and exchange proof of quality, safety, and efficacy of medicinal products. Its team of experts boasts a wealth of experience in regulatory affairs and electronic submissions, specializing in right first time eCTD lifecycle management and regulatory information management. Supported by Dossplorer™, Qdossier’s advanced cloud-based dossier management solution, the firm’s areas of expertise include regulatory information management, lean and structured authoring, IDMP, and regulatory strategy and procedural support. For more information, visit www.qdossier.com.

For further information please contact:

Rachel Hollos

Marketing director at Celegence

rhollos@celegence.com

Press contact:

Fiona Whyatt

Senior PR manager at ramarketing

fiona.whyatt@ramarketingpr.com