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Clinical and Registration
Clinical and Registration
Seamless Transition from R&D to Market Approval
Regulatory Submission Services
We develop highly compliant registration dossiers grounded in actual production data to accelerate market access - from process validation to analytical protocols, from technical documentation to regulatory agency communication.
Registration
service
01
Registration Pathway
Planning
02
Product Technical
Standard Development
03
Registration Testing
Protocol Design
& Lab Coordination
04
Registration Dossier
Preparation
05
Document Submission
Regulatory Agency
Communication
06
Registration Batch
Production Oversight
07
Change Control
Integration
08
Global Registration
Coordination
Clinical Trial Support Services
Providing comprehensive assistance for clients' clinical trials and pre-market studies including screening and evaluating of clinical trial sites, as well as coordination with CROs, testing laboratories, and other third-party vendors to ensure regulatory-compliant study execution.
Quality System Integration
Translate regulatory requirements into executable production standards to ensure full compliance in daily operations.
Across all product lifecycle stages - from R&D and clinical/regulatory affairs to manufacturing, distribution, application, adverse event management, and reevaluation - we deliver dual empowerment through "integrated quality systems and regulatory expertise", enabling enterprises to build sustainable compliance resilience and gain competitive regulatory advantage in dynamic markets.
Registration scope
NMPA
FDA、CE