Regulatory Affairs
MAKING SENSE OF CONFLICTING INFORMATION ON REGULATORY AND DRUG DEVELOPMENT STRATEGY
THE PROBLEm
Some European and American Pharmaceutical companies were receiving conflicting information on the Japanese regulatory and clinical development pathways.
THE SOLUTION
We have carefully assessed each case and provided independent in-depth analyses based on the Japanese regulatory requirements and the scrutiny of precedence in Japan. We have provided a thorough analysis and presented our recommendations. Our detailed assessment reports and follow-up discussions have been useful for these companies to make a decision.