Lifecycle Services
Comprehensive regulatory and pharmacovigilance services supporting your product from development through patent expiry.
Explore ServicesComplete Product Lifecycle Management
From regulatory submissions to post-market surveillance, we provide the expertise and infrastructure you need at every stage.
Regulatory Affairs
Expert regulatory strategy and submission management across all global markets.
- •IND/CTA preparation and submission
- •Marketing authorization applications
- •Post-approval variation submissions
- •Regulatory intelligence and strategy
Pharmacovigilance
Comprehensive safety monitoring and adverse event reporting services.
- •Safety database management
- •ICSR processing and reporting
- •Signal detection and PBRER
- •Risk management planning
Medical Information
Multi-channel medical information services for healthcare professionals and patients.
- •24/7 medical information hotline
- •Scientific literature monitoring
- •Inquiry response management
- •Training and quality assurance
Development Consulting
Strategic drug development consulting from preclinical through commercialization.
- •Clinical development strategy
- •Regulatory pathway optimization
- •Risk mitigation planning
- •Portfolio management