Throughout the entire lifecycle of drugs, enterprises frequently encounter unexpected quality control challenges and strategic compliance decisions. The problems such as the establishment of new production lines, process change, regulatory updates, significant deviations, customer complaints, or official inspection inquiries demand not only in-depth professional knowledge but also swift support from cross-disciplinary practical experience. Internal teams, constrained by resources and experience, often struggle to tackle 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 entire quality chain from research and development to production, and are able to provide enterprises with precise and executablesolutions based on multiple 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 for enterprises, helping them reduce compliance risks and ensuring operational continuity and compliance.
