Business Imperatives

  • A US-based pharmaceutical company had a portfolio of 15 ANDAs/NDAs and products in the pipeline.
  • The purpose was to get the required Regulatory support for managing both new and approved products. 

Objectives

The objective was to manage complete Regulatory operations for multiple products in different therapeutic areas for the client.

Problem Statement

  • Absence of an in-house Regulatory team.
  • Client’s lack of coordination with CMOs/CROs to ensure timely flow of documents.
  • Limited understanding of US FDA requirements for NDA/ANDA submissions.

Freyr Solutions and Services

Freyr Solutions and Services
  • Provided end-to-end Regulatory registration support for initial registrations and lifecycle management (LCM).
  • Conducted health authority (HA) interactions.
  • Assisted with labeling and artwork.
  • Offered publishing assistance end-to-end.
  • Managed complete Regulatory operations. 
  • Eradicated the burden of Regulatory activities for the client.
  • Prepared Regulatory submission strategies and assisted with their execution.
  • Coordinated with CMOs/CROs and ensured the timely flow of documents.
  • Conducted gap analysis and prepared NDA, ANDA, LCM, and pre-submission packages.
  • Supported expansion into other markets.
  • Ensured the continuity of business operations.
  • Achieved zero Regulatory rejections.
  • Eliminated Regulatory burdens on the client.
  • Put Regulatory best practices into effect.
  • Successfully managed complete Regulatory operations for multiple products in different therapeutic areas for the client.