Monday May 9th 2022



Quality by Design (QbD), a privately held company in Belgium offering quality solutions to companies in the life science industry, today announced that it is rebranding as QbD Group to reflect its expansion into new services and markets over the past decade. The Group will continue to serve the wider life science industry, with a strong focus on ATMPs, medical devices, IVDs, and digital health, thanks to the specific expertise that it has built in these areas.

This decision has been driven by QbD’s substantial growth since its foundation in 2011. The small Belgian startup offering expert quality advice has now become a multinational company with over 450 highly-qualified employees, through both organic growth and strategic acquisitions. The time has now come to unify the message about the different support services which will fuel the Group’s ambitions for further expansion worldwide.

QbD Group offers potential clients a range of services within seven new divisions:

  • Regulatory Affairs: We help our clients in their journey throughout the entire drug and medical device regulatory lifecycle.

  • Clinical: We are an expert clinical solutions provider specialized in medical devices and biotech, offering global CRO services and consultancy.

  • Qualification and Validation: We guarantee that products meet quality demands and comply with regulation through the qualification and validation of your processes, equipment, and software.

  • Quality Assurance: We offer the full range of QA services necessary to get your product to market in a safe and compliant way, including auditing from certified auditors, setting up your QMS, and all QP (Qualified Person) activities.

  • Quality Control: Our QC division consists of a GMP laboratory that offers analytical services for testing pharmaceutical raw materials, excipients, and release testing of finished products.

  • Software solutions: Cloud-based and pre-validated Quality Management Software built for the life sciences, as well as eIFU services which enable IVD and MD manufacturers to digitalize paper Instructions For Use (IFU).

  • Go to market: We help you launch your product to market by providing marketing and communication services, business development support and sales strategy.

Bart Van Acker, founder and CEO of QbD, said: “We have always had the mission to offer a full range of services and software solutions to assist companies in developing innovative products, and to this end have been growing our ecosystem through strategic alliances and acquisitions to offer an increasingly wide range of skills and expertise from individual brands that have become successful in their own right. We can now provide the full support needed for companies to develop their ideas into safe and effective solutions for patients.”

About QbD Group:

The QbD Group supports life science companies worldwide throughout the entire product lifecycle - from idea to patient. Since 2011, QbD has been providing quality solutions for product development and manufacturing. The QbD Group’s team offers the skills and expertise for solving complex project problems in quality assurance, validation & qualification, regulatory affairs, clinical, quality control, software solutions and go to market for companies active in the biotech, small molecules, digital health, medical device & IVD industries. QbD Group is headquartered in Belgium and has over 450 consultants worldwide in the Netherlands, Spain, France, UK, Switzerland, Mexico, Colombia and the US. To learn more, visit