In recent years, the significance of statistics in pharmaceutical compliance and quality management has become increasingly prominent. GMP regulatory such as pharmacopoeia, FDA guidelines, and ICH guiding principles all explicitly emphasize the necessity of statistics applications. Meanwhile, statistical analysis has become a fundamental requirement for scientific based quality management. Several companies have been cited for deficiencies due to inadequate statistics applications in recent years.
In addition to meeting compliance requirements, the scientific statistics application can significantly assist companies in optimizing processes, reducing costs, and enhancing product quality and stability. However, effective implementation of statistical analysis necessitates four simultaneous core competencies: knowledge of statistics, process knowledge, regulatory understanding, and practical application experience. The perception that "statistics are useless" often stems from the lack of one or more of these competencies.
gempex has a solid basis in statistical theory and extensive experience in CMC applications throughout the entire drug lifecycle. We are able to provide support with statistical analysis tailored to business and regulatory needs, assisting companies in achieving data-driven decision-making and continuous improvement.
