Many years of experience of working with companies from the pharmaceutical and cosmetics sector have enabled to solve different issues related to data analysis, reporting and statistical control and monitoring of production processes (SPC), to provide comprehensive solutions.
We deliver reliable solutions for the key areas of pharmaceutical and cosmetic product manufacture. With regard to quality, we provide solution for product stability shelf-life estimation and trending, production environment monitoring, process validation and ongoing process verification, periodic product quality review related to statistical analyses, dissolution profile comparison, as well as analytical method uncertainty assessment and validation. In the area of production, we offer statistical process control (SPC) and overall equipment effectiveness monitoring (OEE), we also provide assistance in the scope of measurement system analysis (MSA) and preventive/predictive maintenance (PM). Whereas with regard to technological resources, we offer optimised processes based on design of experiments (DOE) and historical data (Data Mining, CART, CHAID).
We do not only offer single tools for data analysis automation and reporting, but also provide integrated systems which facilitate gathering and analysis of data according to the recommendations of the FDA, EMA and national regulatory bodies with regard to Good Manufacturing Practices (GMP) and Pharmaceutical Quality Systems.
Through our advisory and training services we want to share structured knowledge based on tried and tested solutions, compliant with industry standards and requirements of different auditors.