Gap Analysis CMC comparison

CMC CTD MS Office Word Excel

SOPs GLP GMP Adobe Acrobat

Regulatory domain Java architecture design GxP

Consulting strategic planning client management.

MDR IVDR CAPAs GMP regulation ISO 13485

risk management Clinical Pharmacovigilance/Drug Safety Medical Affairs Supply Chain

Global Regulatory affairs CMC submissions Regulatory Analytics platform SDLC

Biomedical Engineering Engineering European Union In Vitro Diagnostics (IVD) PAC

CMC Regulatory Affairs

Assist Customer Service Technical Support Regulatory Affairs Analytical Services

International Standards Product Management Product Registration Thermal Analysis

Biomedical Engineering Engineering European Union In Vitro Diagnostics (IVD) PAC