QbD Group
Bernd Lafortune is a professional with extensive experience in business development and life sciences. Currently serving as a Business Development Manager (IVD) and Life Science Consultant at QbD since August 2020, Bernd has also held roles as an Assay Process Validation Engineer at Biocartis and a Project Engineer Launch Excellence at Pfizer. In addition, Bernd was involved with LBK, the student association of the Faculty of Bioscience Engineering at KU Leuven, from July 2016 to July 2023, where positions included Board Member and President, overseeing a team of 180 students and representing 1600 peers. Educational qualifications include a Master's degree and Bachelor's degree in Bioscience Engineering, both obtained from KU Leuven.
QbD Group
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.