Quality management professionals in the life sciences industry are facing an ever increasing set of rules and guidelines. Institutions like the European Medicine Agency (EMA) and the American Food & Drug Administration (FDA) are amending and adjusting their regulations and guidelines frequently. On the other side, companies are increasingly outsourcing their production processes to other companies or countries. Pharmaceutical validation is more important than ever but this also applies to the biotechnological and medical devices industry.
Many quality professionals in the industry are experiencing the pressure. How do they guarantee that their products meet quality requirements and comply with regulations? How do they ensure that technology and expertise are transferred efficiently and effectively during outsourcing processes? And how do they document their practices and procedures clearly?
QbD is your quality expert with a well-established reputation in Belgium and the Netherlands. Seventy-five experienced, certified pharmaceutical validation experts, quality assurance specialists and tech transfer engineers are ready to advise and support you wherever they can – whether you want to entrust your project to us, or hire-in our skills. Supported by best practices, experience and our knowledge of the (life sciences) industries we offer quality services, including validation, audits, consultancy and our Lean Technology Transfer Framework. Together, we will face the increasing challenges in quality management for life sciences.