• gempex China Ltd. CN/EN
  • gempex GmbH DE/EN
400-166-2002

Services

Inspection Guidance

ServicesInspection ReadinessInspection Guidance

Given the ongoing integration of the global pharmaceutical market, drug and medical device manufacturers are subject to inspections by GMP authorities from different countries. Whether foreign companies entering the Chinese market or domestic companies expanding internationally, all face significant challenges in responding to on-site inspections within unfamiliar regulatory systems. Companies often lack adequate preparation due to unfamiliarity with target market regulations, regulatory and cultural differences, language barriers, inspection processes, and inexperience - leading to inspection failures and even affect product launch timelines and corporate reputation.

gempex leverages the global expertise (covering China, the U.S., and Europe) and comprehensive regulatory knowledge to provide professional support for domestic and foreign official inspections. We have a deep understanding of the differences in regulatory requirements and key focus areas across major markets, enabling us to help companies quickly identify gaps and develop effective response strategies. Our services not only enhance inspection readiness through customized training and mock inspections but also provide on-site interpretation and emergency support during inspections to ensure smooth communication and appropriate responses. Until now, we have successfully guided numerous companies pass the GMP inspections by official authorities such as NMPA, FDA, and EMA, supporting their products’ entry into target markets.

Service Advantage

International Team
Experts with backgrounds in China, Europe, and the U.S., capable of accurately interpreting and translating requirements across different regulatory systems.

Customized Services
We offer tailored service packages ranging from "fast check-up" to "in-depth improvement" based on urgency due to an inspection and client readiness, meeting individual needs.

20+ Years Practical Experience
Over 20 years of GMP service experience, including direct participation with clients in various official inspections.

Combining efficiency with cost
We provides risk-based and resource-appropriate response strategies, avoiding unnecessary large-scale adjustments and focusing on key regulatory priorities to achieve maximum inspection readiness in the shortest possible time.

Full Support
We deliver hands-on guidance throughout the entire process - from training and mock inspections to corrective action tracking and deficiency response - to ensure thorough preparation.

advantage

Inspection Guidance

  • Assist in formulating the inspection schedule
  • Plan the inspection route
  • Prepare the presentation PPT and the list of inspection materials (including both Chinese and English versions)
  • Provide on-site or remote support, including guidance on the inspection route, preparation of post-inspection room materials, and submission of pre-inspection room materials
  • Assist in real-time issue response guidance
  • Provide translation services