01
China Product Registration
We support drugs, APIs, excipients and packaging through tailored regulatory strategy, dossier gap analysis, CTA submission and end-to-end registration management.
02
Our services
Rigorous advice for every critical interface.
From first China strategy to approval and lifecycle management, our work combines regulatory judgment with scientific depth.
02
Regulatory Affairs Consulting
Our former authority and industry professionals advise on registration strategy, formal meetings, deficiency responses, lifecycle changes and regulatory intelligence.
03
DMPK & Clinical Pharmacology
We provide DMPK, PK/PD, dose selection, modeling and clinical pharmacology support across early development, registration and post-approval stages.
04
Clinical Trial Inspection
We prepare teams for NMPA site inspections through readiness assessment, mock inspection, CAPA planning and focused training against local expectations.
05
CRO Assessment
We assess CRO capabilities, quality systems, delivery risk and China compliance, helping sponsors choose and manage the right operational partner.
06
CDE Communication
We plan and support Pre-IND and other CDE meetings, turning scientific and regulatory complexity into precise briefing materials and actionable outcomes.
METHOD
How we work
Frame
Clarify the product, evidence, decision and regulatory context.
Diagnose
Identify gaps, dependencies and the highest-value interventions.
Direct
Build a practical roadmap with clear owners and decision points.
Deliver
Support execution, authority communication and course correction.