Ensure full EU and global regulatory compliance for your medical products with expert guidance.
Overview
Globaxa facilitates contract manufacturing partnerships that enable pharmaceutical companies to scale production, access specialized capabilities, and optimize manufacturing costs while maintaining stringent quality standards. Our comprehensive third-party manufacturing coordination services cover the entire product lifecycle from technology transfer to commercial supply.
Manufacturing Coordination Services
Contract Manufacturing Organization (CMO) Selection
- Detailed capability assessment and matching
- Technical capability evaluation
- Capacity and scalability analysis
- Quality system assessment
- Regulatory compliance verification
- Commercial terms negotiation support
Quality Assurance & Compliance
- Quality agreement development and implementation
- GMP compliance monitoring
- Audit coordination and management
- Batch documentation review
- Certificate of Analysis verification
- Regulatory inspection readiness
- Annual product quality review (APQR) support
Supply Chain & Logistics
- Production planning and scheduling
- Raw material procurement coordination
- Inventory management
- Packaging and labeling coordination
- Finished product release and distribution
- Serialization and track-and-trace compliance