Meeting with FDA

We help our clients preparing meeting packages, and represent our clients in the face to face meeting with FDA including PIND meeting, End of Phase 2 meeting, Pre-BLA meeting, and Biosimilar specific product development meetings. 

IND Filing

We will perform gap assessment, review and help our clients to prepare the filing documents.

  

Others

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". The managing includes annual reports, adverse events reports, and manufacturing changes reports. 

IND Maintenance

Our goal is to serve the clients to ensure the smooth drug development. Whenever you need, whether it is to address the clinical hold issues, or manufacturing facility GMP inspection or represent your company to give an important talk, we are always there for you. 

Our clients

We have helped our clients in the US, Europe and Asian countries successfully to start their IND and drug development in the US. We can also be your regulatory agents for the US FDA interaction.