CMC

Manage and execute tech transfers (manufacturing and/or testing)
Manage and execute manufacturing process validation (strategy, protocol, report)
Review of historical source documents to support regulatory submissions (NDA, BLA, MAA)
Review of existing specifications, manufacturing processes and analytical procedures vs. approved dossiers
Preparation of regulatory documents to support clinical trial applications, marketing applications, annual reports and variations
Support the drafting and/or review of technical documents
Support with implementation of Quality by Design

Web Development Hudson Horizons