IND and NDA filing assistance
IND and NDA filing assistance
FDABasics can act as your US Agent for the purpose of filling your INA and NDA applications. We can assist you with organizing meetings with FDA, any dispute resolution, and follow up on your regulatory project review . FDABasics can also compile your NDA in eCTD format and submit through our ESG.
Get Started with these Top Drug Establishment Forms
- US Agent for Foreign Establishment
- Drug Establishment Registration Form
- NDC Labeler Code Form
- Drug Listing Form
- GDUFA Self Identification Form
- Drug Establishment FEI Number Form