Pre-ANDA submission is a formal written request for feedback from the USFDA to assist applicants with generic application preparation. Before submitting a generic application for complex generic drug products, manufacturers may require pre-submission meetings with the USFDA to get clarity to develop a substantially complete ANDA application, Regulatory expectations in the early product development stage and reduce the number of review cycles to obtain ANDA approval.
Additionally, pre-ANDA submission includes requesting a facility self-identification that enables fast, accurate and reliable inspection of generic drugs globally and facilitates compliance to Regulatory standards. Before filing a request for a pre-submission meeting, the applicant must choose the correct pathway (Product Development, Pre-submission or Controlled Correspondence), provide enough information and follow the guidance of ANDA meetings with the USFDA.
The agency has different criteria and timelines to accept the applicant’s request for pre-ANDA submission meetings. Freyr has been assisting its clients with various pre-submission meetings and other administrative activities during and post the meeting for effective ANDA assessment. Our Regulatory experts help clients to understand the exact HA requirements and accordingly prepare and submit the meeting packages within the proposed timeframe through the USFDA electronic gateway.
Submit a pre-ANDA meeting request to the USFDA
Preparation of a suitable Regulatory strategy (product development, pre-submission or controlled correspondence) before filing a pre-ANDA submission request
Requesting scientific advice from Regulatory Authorities before ANDA submission for complex products
Compilation of scientific justification in case of rejection of pre-submission meeting request
Evaluation and preparation of Regulatory response action plan