Suppliers audits vs worldwide GxP regulations 
APIs, excipients, packaging materials, storage sites, 
services, manufacturing and testing sites

GxP Training 
Quality System Managenent
GxP Documentation
EU/US-FDA/PMDA regulations for Quality Systems, 
Quality Control
APIs, SODs & Sterile Manufacturing
Qualification, Calibration
Cleaning and Process Validation
Data Integrity 

Inspection readiness preparation, Mock inspections 
vs worldwide regulations: ICH / PICs / WHO / EMA / 
FDA / PMDA / TGA / HC / MoIT / GCC / ANVISA

EU QP services: 
QP documentation review & QP EU Release

Regulatory Services: 
Applications review & life cycle management