Our quality team brings deep risk management expertise and thorough regulatory knowledge. We provide sponsors with essential compliance consulting, oversight, and inspection — ensuring trial conduct aligns with the protocol and all applicable regulations. We deliver:
Project Management & Communication Plan
Vendor / Site Assessment & Selection
Protocol & Essential Document Review & Improvement
Project Risk Management & Audit Plan
Issue Tracking & CAPA Confirmation
Regulatory Submission Document Review
Pre‑Inspection / Pre‑NMPA Inspection Preparation & On‑Site Support
Post‑Inspection / Post‑Registration Follow‑Up
