Few industries are more exposed to risk than the life sciences and medical industries, as issues with quality or patient safety can result in very high legal claims. That’s why our consultants, engineers and other experts offer specialized knowledge, expertise and software in the fields of validation, quality assurance, regulatory affairs, clinical and project management. In our activities, we always work with a risk-based, project plan approach, focusing on what’s really important. This way, we increase efficiency, reduce workload and total compliance costs while guaranteeing optimal quality, safety and compliance of products.
As a full-service partner, QbD supports you in a flexible way – from small issues to large projects. Our project plans and services vary from short-term and long-term consultancy to a Quick Scan, taking care of complete projects or working together according to our unique Academy Model.
Our Quick Scan includes a thorough on-site risk assessment of your ISO and GxP compliancy. The result is a detailed report, including problem definition, gap analysis and CAPA list with critical actions, which you can tackle alone or with QbD.
We offer highly educated young professionals for your temporary projects. They receive relevant training, while gaining on-the-job experience. For you, it’s the perfect way to efficiently manage projects and resources and you get the chance to hire the trainee yourself after 14 months.
Within any regulated quality system, an audit process is required for its approval. This includes both internal and external audits.