Enterprises in the fields of life sciences such as pharmaceuticals may have various needs for improvement of existing or newly established quality management systems, e.g., planning to enter the high-end regulatory market and being not sure whether the quality system can meet the regulatory requirements of the target markets; or in case of an existing system for many years and hoping to optimize and improve the complex system; or maybe plan for a new system with sufficient resources but hope to leverage the high-level consulting companies for compliance review.
gempex provides GMP quality system compliance review services based on project experience and professional GMP knowledge, which covers the system integrity, compliance check and process optimization.
High-compliance services in a cost-effective way
Well established workflow to ensure appropriate communication and understanding of key feedbacks
Coverage of multi-field customers (chemical drugs, biological drugs, raw materials and package, medical devices, etc.)