Our Services
PHARMACEUTICALS
Pharmaceutical Regulatory Services
eCTD–based SFDA submissions — from biologics to generics, variations to renewals
Registration & Submission
- New Drug Applications (NDAs)
- Biologics & NCE Submissions
- Generic Drug Submissions
- Full eCTD Dossier Compilation
- Validation Report Preparation
Registration & Submission
- SFDA Portal Access & Filing
- Deficiency Letter Management
- Response Preparation & Re- submission
- Appeal Preparation & Management
- SFDA Communication Follow-up
Registration & Submission
- Type I & II Variation Applications
- Renewal Applications
- Variation eCTD Publishing
- Post-Approval Change Management
- Lifecycle Compliance Support
Registration & Submission
- SmPC & PIL Amendments
- Packaging Artwork Compliance
- SFDA Classification Applications
- Cosmetics Product Listing (GHAD)
- Regulatory Consulting (hourly)