Business Imperatives

  • A US-based pharma incorporation, with over 4 years of association with Freyr, approached us for end-to-end Regulatory support.
  • Freyr managed client support and maintenance activities, overseeing surveillance across 70+ ANDA/NDAs with supplements and necessary documentation.
  • Freyr initiated and monitored necessary Regulatory support, leading to seamless workload distribution for the client.

Objectives

The objective was to provide comprehensive support for ANDAs and NDAs submission, as well as to conduct end-to-end Regulatory operations for over 70 products across multiple therapeutic areas and product types.

Problem Statement

  • A limited number of resources were available to look after Regulatory CMC activities due to a high attrition rate.
  • Lack of expertise in the management of end-to-end Regulatory services.
  • Inability to manage over 70+ ANDAs/NDAs lifecycle management with a limited number of RA CMC associates internally.

Freyr Solutions and Services

Freyr Solutions and Services
  • End-to-end registration support was provided for 70+ ANDAs.
  • Staffing was enabled for various Regulatory imperatives.
  • Support was provided in ANDAs/NDAs/BLAs submission.
  • Dedicated on-site Regulatory Experts and offshore Regulatory experts were assigned in the client’s preferred time zone.
  • Additional buffer resources were allocated to accommodate ad-hoc requests and manage work volumes.
  • Regulatory Associates were assigned for ANDAs/NDAs/BLAs.
  • Responsibility for Regulatory Strategic guidance was assigned.
  • End-to-end registration support was provided for 70+ ANDAs.
  • Business continuity was ensured.
  • Overhead cost benefit was provided to the client.
  • Maintenance of registration requirements for client products was ensured.
  • The objective was achieved through the provision of comprehensive support for ANDAs and NDAs submission, as well as the execution of end-to-end Regulatory operations for over 70 products across multiple therapeutic areas and product types for the US market.