Biologic and Drug Regulatory Consulting
Meeting with FDA
We help our clients to prepare meeting packages, and represent them in face to face meetings with FDA, including PIND meeting, End of Phase 2 meeting, Pre-BLA meeting, and Biosimilar specific product development meetings.
We will perform gap assessment and review, and help our clients prepare the filing documents.
The life cycle of an IND can last many years before it is time to file for a BLA. We help our clients to manage their IND after it is “safe to proceed”, including annual reports, adverse events reports, and manufacturing changes reports.
We have helped our clients in the United States, Europe, and Asia successfully start their IND and drug development in the United States. We can also be your regulatory agents for USA FDA interaction.