- Comparability studies during the development stages
- Pre-IND meeting planning and strategy
- Clinical-phase-appropriate regulatory compliance in the development and establishment of manufacturing and control strategies for biologics and biosimilars (continued from day 1 for later stage products).
- Process development and validation
- Post approval changes
- Adventitious agent risk management
- Sterility Assurance/Aseptic Processing
*The agenda may vary based on changing requirements.