Life Cycle Management
Products & Services
Information
* REGULATORY AFFAIRS AND OPERATIONS
Regulatory Affairs
Regulatory Operations
CMC
* QUALITY AND COMPLIANCE
Quality Assurance and Qualified Person Services
Quality Management System (QMS) & GxP Audit Services
Engineering Consulting, Qualification & Validation Services
* SAFETY AND VIGILANCE
QPPV and Local Safety Officer/Responsible Person
Medical Information (MI)
Literature Monitoring
Individual Case Safety Report (ICSR) Management
Aggregate Report and Risk Management Plan
Signal Management
