Tools for continuous improvement

Product safety and risk assessment in the pharmaceutical, biopharmaceutical and medical device sectors are aspects that are already of lasting importance in R&D. You will gain efficiency and precision if you consider today what will be required of you by regulations in the future.

Standardized industrial and regulatory quality management systems (GxP, ISO, …) and guidelines (OECD, ICH, …) are used worldwide to ensure the validity and traceability of data, processes and decisions in the life science sector.

In the early R&D phase, these standardized quality assurance systems are not necessarily suitable for promoting creative solutions to problems in research and development – or for developing innovative products. The challenge for quality management in this phase is therefore to create space for creativity and problem solving and yet generate reliable data.

PhaToCon provides tried-and-tested consultancy and management services in all aspects of preclinical toxicology and accompanying quality management. Processes for change control, deviation management, CAPA (corrective and preventive action) or risk management are the tools for your continuous improvement.