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US IND APPLICATIONS

Having completed a successful pre-IND meeting with FDA, pharmaceutical companies seeking to market a new drug in the US must file a formal Investigational New Drug (IND) application with FDA prior to each major phase of the clinical trial.

In addition to arranging and preparing for the pre-IND meetings, Donawa Lifescience Consulting (DLC) can also assist companies with end of Phase 2 (EOP2) meetings, and help develop IND submissions and amendments.

DLC is also able to assist companies with pre-NDA/BLA meetings and development of NDA/ANDA and BLA submissions.

Please contact us for additional information.