WuXi STA sell "Global Regulatory Affairs & CMC Submission Support"
Basic Information
702
26
15
3.9(74)
Category
Subcategory & Sub-subcategory
Trade Type
Sell
Service Name
Global Regulatory Affairs & CMC Submission Support
Service Provider(s)
Specifications
- Application: Full CMC documentation support for IND, CTA, MAA, and NDA filings in Western countries and China, including Module 2/3 dossier preparation.
- Regulatory Status: Supports NCE programs through forward-looking regulatory gap analysis ahead of filing.
- Certification Standard: Manufactured under an ISO 9001 quality management system with GMP-compliant production controls.
Documents
FDA
GMP
ISO
Ratings
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