We specialize in providing comprehensive regulatory certification support for domestic API, drug product, and pharmaceutical intermediate manufacturers, assisting companies in successfully passing on-site inspections by global health authorities.

1. End-to-End Certification Services:

Pre-Inspection Preparation: Gap analysis, mock audits, critical deficiency remediation.

Inspection Readiness: Scientific inspection strategy development, training, Q&A simulations, on-site interpretation/guidance.

Deficiency Resolution: Rapid response to 483s/Warning Letters with science-driven CAPA plans.

2. Key Market Coverage:

US FDA certification/on-site inspections

EU/EDQM certification/on-site inspections

Other Markets: WHO-PQ, Brazil ANVISA, PIC/S members (e.g., Japan PMDA, Korea MFDS, Australia TGA), African countries.

1. High Pass Rate: Assisted 100+ companies in passing official inspections.

2. Extensive Experience: Practical expertise in regulatory logic and inspection focus prediction.

3. Multilingual Support: Chinese/English, Chinese/Japanese, Chinese/Korean, etc.

1. Chinese pharmaceutical companies planning to enter international markets

2. Overseas enterprises requiring NMPA compliance inspections

3. Export manufacturers needing to restore certifications after import bans