Covering the entire process from drug-device combination product development through global registration submission, accompanying products throughout their complete development lifecycle starting from project initiation
Core Services
Strategic Planning & Product Development
Deep engagement from the project initiation stage to formulate an overall development strategy for drug-device combination products tailored to target markets, defining development pathways, regulatory classifications, key technical milestones, and global registration plans to establish a clear project roadmap.
Collaborative Development System
Guiding the establishment of a development system compliant with FDA, EMA, NMPA, and other regulatory requirements throughout the combination product development lifecycle.
Making drug-device combination product development simpler, and global registration more efficient.
— PDX Service
Global Regulatory Strategy & Regulatory Communication
Formulating global registration strategies for major markets including China, the United States, Europe, and Australia, and facilitating
Cross-Disciplinary Expert Team
Pre-IND / Type C Meetings
Team
- Integrating professional capabilities across
- CMC, biologics
- Drug delivery devices,
- Medical device R&D
- Human factors engineering
- International registration
- Quality systems to deliver genuine drug-device integrated consulting
POX
International RA Experience
Technical Consultations
Expert
- Deep familiarity with the regulatory frameworks and communication mechanisms
- FDA, EMA, NMPA, TGA, and other major markets
- Enabling the development of registration strategies that meet global market entry requirements.
Full-Lifecycle Service
Communication Meetings
Flexibilty
- The entire process from project planning, development, verification, regulatory communication,
- Registration submission through review Q&A
- Delivering true end-to-end partnership.
Making drug-device combination product development simpler, and global registration more efficient.
PDX will continue to build on the development philosophy of “Packaging × Delivery × X-service,” continuously expanding its professional services in pharmaceutical packaging, drug delivery devices, drug-device combination products, and regulatory science, working alongside more partners to drive the advancement of China’s injectable drug-device combination product industry.