1. End-to-End Technology Transfer Management

· Process transfer from lab to production (including scale-up feasibility assessment)

· Analytical method transfer (AMT) protocol design and execution

2. Compliance Support

· Preparation of Technology Transfer Protocols (TTP) and risk control matrices

· Cross-system documentation conversion for FDA/EDQM/NMPA submissions

3. Resource Coordination

· GMP-compliant CMO matching (including capacity audit reports)

· Recommendation of GLP/GCP-certified testing facilities

4. Validation Support

· Protocol development for Process Validation (PV) and Cleaning Validation (CV)

· Continued Process Verification (CPV) supervision post-transfer

1. Cross-Functional Expert Team

· Integrated team covering process development, GMP manufacturing & RA registration (avg. 15 years’ experience)

2. Dual Compliance Assurance

· Simultaneously meets regulatory requirements for both sending & receiving sites

· Deficiency early-warning system

3. Cost Optimization

· Risk-based tiered approach to minimize non-essential validation efforts

1. Pharmaceutical companies requiring cross-site/international product transfers

2. MAH-licensed holders needing CMO technology bridging

3. Innovator drugs transitioning from clinical to commercial manufacturing

4. Generic manufacturers coordinating BE studies for consistency evaluations