Business Imperatives

Innovative Drug Research and Development Company needed help in preparation and submission of Type B Pre-IND meeting request and meeting package to FDA.

Objectives

The objective was to assist an Innovative Drug Research and Development Company with the preparation and submission of a Type B Pre-IND meeting request and meeting package to the FDA, ensuring regulatory compliance and facilitating a smooth submission process.

Problem Statement

The client lacked prior experience in submitting Type B Pre-IND meeting requests and associated meeting packages to the FDA, which posed a challenge in navigating the regulatory requirements and preparing the necessary documentation for a successful submission.

Freyr Solutions and Services

Freyr Solutions and Services

Freyr provided comprehensive support and addressed all challenges faced by the client. The solutions included:

  • Preparation of the Type B Pre-IND meeting request and meeting package in accordance with FDA requirements.
  • Re-framing of the meeting questions and making necessary modifications to the content, particularly related to non-clinical study design, IND content, and starting dose selection rationale.
  • The Type B Pre-IND meeting request and package were submitted on time.
  • The client gained a comprehensive understanding of the FDA’s expectations and probable responses to their questions.

Freyr successfully assisted the Innovative Drug Research and Development Company in preparing and submitting the Type B Pre-IND meeting request and meeting package to the FDA. This ensured full regulatory compliance and facilitated a smooth submission process, helping the client move forward with their drug development program efficiently.