Adelheid
Kotitschke
adelheid.kotitschke@arcondis.com Compliance Services Lead, Leadership, Project/Portfolio Management
End-to-end process validation and qualification from single equipment up to complete facilities
At Arcondis, we have developed a deep understanding of the unique challenges faced by the Life Science industry, particularly in pharmaceuticals and MedTech. This understanding has led us to specialise in the field of qualification and validation, as we recognise its pivotal role in guaranteeing the safety and effectiveness of end-to-end processes throughout the entire product life cycle. From the production of initial clinical batches to the delivery of commercial products, we are committed to ensuring optimal patient outcomes by implementing robust qualification and validation practices.
Through our stringent quality control measures, we assist drug manufacturers in minimizing the production of substandard or contaminated medications, safeguarding patient safety, meeting regulatory requirements, and guaranteeing the effectiveness of medicines. We support our clients throughout their journey towards intelligent commercial production by establishing a holistic qualification process. Our approach ensures that all members of the client's team are aligned and working towards a common goal, fostering collaboration and maximizing efficiency. Furthermore, we optimize the client's organization by implementing a clear division of tasks, streamlining operations, and enhancing productivity.
Ultimately it is about enabling our clients to produce important medicines and devices. Qualification is one of the key success factors. Routine production and clinical production have to work for the client and need to be part of the QM systems.
Compliance Services Lead, Leadership, Project/Portfolio Management
Strategic Compliance and Quality Management
Compliance Services Consultant