Regulatory Support
Our regulatory affairs team provides comprehensive support to ensure compliance with global pharmaceutical regulations and standards. We help navigate the complex regulatory landscape while maintaining the highest quality standards.
Regulatory Strategy
- • Global regulatory pathway assessment
- • Registration strategy development
- • Pre-submission consultations
- • Risk assessment and mitigation
- • Post-approval maintenance
Documentation Support
- • Technical document preparation
- • Dossier compilation
- • Label development
- • Safety updates
- • Regulatory correspondence
Global Regulatory Expertise
North America
- • FDA regulations
- • Health Canada requirements
- • Mexican regulatory standards
Europe
- • EMA guidelines
- • National authorities
- • Brexit implications
Asia Pacific
- • PMDA (Japan)
- • NMPA (China)
- • Other APAC markets
Compliance Services
Quality Compliance
- • GMP compliance
- • Quality system review
- • Audit preparation
- • CAPA management
Safety Compliance
- • Pharmacovigilance
- • Safety reporting
- • Risk management
- • Post-market surveillance