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, without the improvement of professional proficiency among domestic and foreign inspectors, statistical analysis has become a fundamental requirement for scientific quality management. Several companies have been cited for deficiencies due to inadequate statistics applications in these years.
In addition to meeting compliance requirements, the scientific statistics application can significantly assist enterprises in optimizing processes, reducing costs, and enhancing product quality and stability. However, effective implementation of statistical analysis necessitates the simultaneous possession of four core competencies: statistical knowledge, 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.
gemepx possess a solid foundation in statistical theory and extensive experience in CMC applications throughout the entire drug lifecycle. We are capable of providing statistical analysis support tailored to business and regulatory needs, assisting enterprises in achieving data-driven decision-making and continuous improvement.
