Business Imperatives

A U.S.-based biopharmaceutical company sought support for IR response preparation, strategy, and expert guidance.

Objectives

To ensure timely and accurate regulatory compliance by strategizing, preparing, and responding to Information Requests (IR) for the Investigational New Drug (IND) application, in alignment with USFDA guidelines.

Problem Statement

The timely submission of the IND application and IR response was critical to maintaining compliance with USFDA regulations. Any delays or inaccuracies could have resulted in non-compliance, potentially leading to regulatory actions or delays in the drug development process.

Freyr Solutions and Services

Freyr Solutions and Services

Freyr has provided complete support and addressed all the challenges from client, Solutions includes:

  • Provide response strategy for the IRs
  • Provide expert advice on response content and section updates
  • Best regulatory strategy for the client’s need
  • Timely submission of Pre-IND meeting request

The IND application strategy, preparation, and IR response were successfully executed and submitted to the USFDA in a timely and compliant manner. By adhering to all regulatory guidelines, the submission process was streamlined, avoiding delays or compliance issues, and ensuring the client's continued regulatory adherence.