01
China Product Registration
A practical, risk-led path from dossier review to market approval.
01 / SIJUAN
Global teams, China execution
Senior experts directly involved
Science integrated with regulation
Strategy through approval
Core capabilities
Expertise across the development continuum
Senior-led, cross-functional support for the moments that determine program speed, quality and probability of approval.
02
Regulatory Affairs Consulting
Decisions grounded in current policy, review logic and CDE expectations.
03
DMPK & Clinical Pharmacology
Integrated evidence strategies connecting exposure, response and development decisions.
04
Clinical Trial Inspection
Inspection readiness built around evidence, process and execution.
05
CRO Assessment
Independent due diligence for confident partner selection and oversight.
06
CDE Communication
Clear questions, defensible positions and productive authority interactions.
Scientific depth
WHY SIJU’AN
Built for consequential decisions
Scientific depth is valuable. Regulatory clarity makes it actionable.
01
Authority insight
Experience shaped inside China’s drug evaluation and inspection system.
02
Scientific leadership
Decades of pharmaceutical science expertise, including Professor Ikumi Tamai.
03
One integrated view
Regulatory, DMPK and clinical pharmacology considered together—not in silos.
A clear working model
From scientific question to regulatory action.
Each engagement is structured around a decision, a defensible evidence position and a practical route to execution.
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.
SIJUANCONSULTING@163.COM
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