Navigating Challenges in CMC Package Submissions

Time: 11:30 am
day: Conference Day Two


  • Addressing the challenge of limited batch data, including the proposal to manufacture additional batches for compatibility testing
  • Emphasizing the need for forward-thinking strategies in transitioning from experimental processes to commercially viable ones
  • Exploring the regulatory landscape and how regulatory agencies, such as the FDA, respond to innovative approaches
  • Highlighting the importance of risk assessment in justifying the analytical approach and how this can influence regulatory decision-making