Business Imperatives

  • A Japanese drug manufacturer, expanding its operations to the United States, sought to optimize its submission process to meet US Regulatory requirements.
  • Freyr, a leading Regulatory solutions provider, was engaged to manage and enhance the entire submission lifecycle.

Objectives

To enhance and streamline the submission process for a Japanese drug manufacturer expanding into the US market, thereby accelerating the approval cycle, and ensuring compliance with US Regulatory standards.

Problem Statement

  • The client previously lacked complete standardized submission processes.
  • Transitioning from the existing vendor’s Regulatory Information Management System (RIMS) was daunting.

Freyr Solutions and Services

Freyr Solutions and Services
  • Managed all aspects of IND-original and Lifecycle Management (LCM) submissions.
  • Developed and implemented standardized submission processes to enhance efficiency and compliance.
  • Handled all stages of the submission process, from planning to publishing and final submission to US Regulatory bodies.
  • Assessment and Planning: Conducted a thorough analysis of the existing submission processes and identified key areas for improvement.
  • Transition Management: Seamlessly transitioned the submission process from the existing vendor’s RIMS to Freyr’s system.
  • Process Standardization: Developed and deployed standardized procedures for submission preparation and management.
  • Training and Support: Provided comprehensive training and ongoing support to ensure the client's team could efficiently manage the new processes.
  • Execution: Managed and executed all submissions, ensuring compliance with US Regulatory requirements and facilitating timely approvals.
  • Accelerated Regulatory approval process.
  • Ensured strict compliance with Regulatory requirements.
  • Streamlined processes for improved productivity.
  • Offered expert guidance to navigate complex regulations.

The Japanese drug manufacturer successfully transitioned to a standardized submission process, leading to faster approval cycles and successful market entry in the United States. The enhanced processes ensured compliance with US regulations, reduced operational inefficiencies, and facilitated smoother Regulatory interactions.