Regulatory

IND / CTA / BLA / NDA eCTD Submission

Consulting

US/China IND

  • Gap Analysis
  • Pre-/Pre-IND Briefing Package Preparation
  • Pre-/Pre-IND Meeting Rehearsal
  • Write/Review eCTD package
  • CMC Data
  • Non-Clinical Data
  • Investigator Brochure
  • Non-Clinical SEND
  • FIH Clinical Trial Design
  • FIH Clinical Trial Protocol
  • US IND eCTD Dossier ESG Submission
  • China IND CTD Submission
  • US IND Annual Report eCTD Preparation
  • US IND Annual Report eCTD ESG Submission

Regulatory Strategy

  • Candidate Character
  • Competitive Landscape
  • Regulatory Guidances
  • Regulatory Pathway
  • Clinical Strategy
  • Go/No-Go Milestones
  • Submission Waves
  • CDS/Label Updates
  • Advertising Validation
  • Lifecycle Management
  • Compassionate Usage

US/China NDA/BLA

  • Gap Analysis
  • End-of-Phase-2 Briefing Package Preparation
  • End-of-Phase-2 Meeting Rehearsal
  • Write/Review eCTD package
  • Module 1-5 Documents
  • Clinical Summary
  • Clinical Safety Summary
  • Clinical Efficacy Summary
  • Label/CDS
  • Clinical Study Reports
  • Clinical eSub Datasets
  • eCTD Dossier Preparation
  • eCTD Dossier QC Review
  • eCTD Dossier Publishing
  • eCTD Dossier ESG Submission