U.S Agent services for DMFs ( Drug Master Files) and

ANDAs (Abbreviated New Drug Applications).

Services include:
 

a.    Annual Report review and filings
b.    Amendment review and Filings
c.    Issuance of authorization letters to ANDA holders
d.    Organizing FDA inspections of manufacturing facilities
e.    Technical guidance on how to proceed with ROS changes and etc.,
f.     US agent referral authorizations to FDA and ANDA holders.