The QbD Group supports life science companies worldwide throughout the entire product lifecycle – from idea to patient. We are a multinational company with over 450 high-qualified employees.

Our experienced team serves the wider life science industry, with a strong focus on ATMPs, medical devices, IVDs, and digital health, thanks to the specific expertise we have built in these areas. The services we offer fall under the following 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.

Clinical Trials

Medical Devices

Quality Assurance

QbD Group

Bart Van Acker

Jose Decolsa

Jaime C.

Tom Lokermans

Luc Segers

Jonathan Boel

QbD Group

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