QbD

The QbD Group supports life science companies worldwide throughout the entire product lifecycle – from idea to patient. We are a global company with over 650 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.