Throughout the entire lifecycle of drugs, companies frequently encounter unexpected quality management and control challenges and needs for strategic compliance decisions. The problems such as the establishment of new production lines, process changes, regulatory updates, significant deviations, customer complaints, or official inspection inquiries demand not only in-depth professional knowledge but also fast support with cross-disciplinary practical experience. Internal teams, constrained by resources and experience, often struggle to deal with these complex challenges independently.
gempex provides efficient and professional routine quality consulting services, as a GMP compliance partner with over 20 years of deep industry experience. We gather senior experts from around the world, covering the topics of the entire quality chain from research and development to production, and are able to provide companies with precise and executable solutions based on various national regulations (including NMPA, FDA, EMA, etc.). Whether it's emergency handling of sudden quality incidents or the formulation of forward-looking compliance strategies, gempex can serve as a reliable external quality partner helping companies to reduce compliance risks and ensuring operational continuity and compliance.
