In recent years, domestic pharmaceutical enterprises are facing great competitive pressure with the development and change of pharmaceutical industry regulation environment at home and abroad, such as centralized procurement policies and MAH system policies, etc. Therefore, how to improve own comprehensive compliance level, optimize own resources and accelerate internationalization, become significant topics in the industry.
In addition, for those new set-up factories or pharmaceutical enterprises that have been operating for many years, when facing authority inspection at home and abroad, they may miss confidence to determine whether the existing system has potential deficiencies and can meet the regulatory requirements, or they may know the gaps in place but are not sure how much and how to improve, or they would like to enter a new market, but have not much experience whether special regulations requirements or concept required and then how to optimize the existing system.
With many years of experience in GMP projects, gempex has the capabilities to accurately identify the deficiencies and deviations in the GMP systems and provide comprehensive analysis reports with listed observations, suggestions for corrective and preventive actions and prioritization of identified gaps. In addition, we provide improvement support, progress tracking, on-site consulting or GMP inspection accompany etc. services, to ensure projects achieve the goals effectively and with high quality.
Detailed, in-depth and comprehensive analysis from the perspective of the international team
A comprehensive gap analysis evaluation report with detailed listing of findings and recommendations for improvement (Diversity language choices Chinese/ English/German)
GMP consultants follow-up supports including GMP inspection support, to ensure projects’ success
