Global Regulatory Affairs & CMC Submission Support
Product
Information
WuXi STA's dedicated Global Regulatory Affairs CMC teams offers comprehensive CMC documentation support for IND, CTA, MAA, and NDA applications in western countries and China. Our highly experienced team works with your NCE programs to prepare Module 2 and Module 3 of your regulatory dossier through forecasted gap analyses and meticulous preparation of source documents. This can add tremendous value to your development program, dramatically expediting your speed to market. Services Include: - CMC Dosser Preparation & Technical Review for USA, Europe, and China - Strategy, Planning, & Feasibility Consultation - Regulatory Contribution Guidance - Gap Analyses & Support Services - Document Translation Services
Main Categories
Biopharmaceutical ProductsContract Development and Manufacturing Organisations (CDMOs) and Contract Manufacturing Organisations (CMOs) (Services)
All Categories
Regulatory AffairsChemistry, Manufacturing and Controls (CMC)
