Looking for experienced life sciences consultancy or a consultant? Then you’ve come to the right address. More than 180 consultants, engineers and other experts are ready to help and address your needs. You can either entrust your projects to our consultants or benefit from their skills on a more ad hoc base. One of our biggest strengths? Our flexibility. We are proud to be a full-service partner in our four main fields of action: validation, regulatory affairs, quality assurance and project management and support.
Many companies are struggling with validation or quality management in highly regulated sectors. QbD can quickly offer a quality consultant with the right experience and skills for short-term and long-term projects. Unsure of how much manpower you need? Then we offer you a co-sourcing model to cater for peak periods in project work.
Validation Validation of processes, equipment and software is important to guarantee that your products meet quality demands and comply with regulations. We offer consultants that are experienced in validation of cleaning processes, analytical methods, warehouses & transport lanes, and qualification of equipment and facilities. In addition, we support you in Computerized System Validation (CSV) and data integrity.
Regulatory affairs Besides quality management, we also support you throughout the entire drug or medical device regulatory lifecycles. Our regulatory affairs consultants support companies in traditional pharmaceuticals, generics, cosmetics, vaccines, biologicals or biosimilars, medical devices or Advanced Therapy Medicinal Products (ATMPs). Our expertise includes CMC, registration, post marketing surveillance, regulatory compliance, safety technical files and more.
Quality assurance To guarantee the quality of processes and products within your organisation, our quality assurance experts offer advice and support regarding the implementation and maintenance of Quality Management Systems (QMS) when it comes to ISO9001, ISO13485 and GxP. Whether it regards to logging deviations, documenting events, performing root cause analyses, following up CAPA, initiating change controls: we work in a risk-based, pragmatic and structural way to guarantee optimal quality management. This also includes internal and external audits and services regarding Qualified Persons (QPs) and Responsible Persons (RPs).
Project management and support Many of our project engineers are certified in PRINCE2, a leading methodology for project management. They work in a pragmatic, structured way, devoting much attention to documentation and communication. Among others, they carry out activities like technology transfer, new product introductions, process development and support, packaging and serialisation, process industrialisation, master batch recording (MBR) and process automation.