Business Imperatives

A USA-based pharmaceutical consultant required expert regulatory assistance for the review and submission of the YY201 IND (Investigational New Drug) application to the USFDA. The scope included providing regulatory strategy, reviewing the application, and ensuring its compliance with FDA regulations for timely submission.

Objectives

The objective was to support the client in preparing a compliant IND submission, addressing any regulatory gaps, and ensuring successful submission to the USFDA.

Problem Statement

The client faced challenges due to limited understanding of the regulatory submission process for IND applications. Additionally, they lacked experience in preparing Module 1 content and aligning it with USFDA expectations.

Freyr Solutions and Services

Freyr Solutions and Services
  • Regulatory Strategy: Freyr provided a tailored regulatory strategy aligned with the client’s requirements.
  • Document Review: Comprehensive review of the client-prepared IND application was conducted to identify gaps.
  • Expert Guidance: Provided detailed feedback on Module 1 content to ensure compliance with FDA regulations.
  • Compliance Assurance: Ensured the application adhered to the USFDA guidelines for a smooth review process.
  • Regulatory Compliance: Ensured complete alignment with FDA requirements.
  • On-Time Submission: Facilitated timely submission of the IND application.
  • Enhanced Understanding: Provided the client with a clear understanding of regulatory expectations and probable FDA responses.

Freyr’s regulatory support enabled the client to successfully submit the YY201 IND to the USFDA. The client gained valuable insights into FDA expectations and regulatory requirements.