Business Imperatives

  • The client had undergone site transfer and name change activities and wanted to create/update all labels and artworks with the new company name and address details.
  • Struggling with creating/updating labels for over 1500 artworks, they sought a partner to ease this labeling/artwork activity.

Objectives

The objective was to provide comprehensive end-to-end labeling support for multiple products within the topicals and dermatology portfolio, including SPL review activities, Change controls, and Printer Proof Regulatory approvals.

Problem Statement

  • The client faced challenges in getting labels that met Regulatory standards. They had to update the company name and address details by creating new artwork with the existing labeling content.
  • The client had a smaller team, posing challenges in efficiently handling labeling tasks.
  • Due to the large volume of documents to be handled, the client sought a partner to assist with the workload.

Freyr Solutions and Services

Freyr Solutions and Services
  • Structured Product Labeling (SPL) review activities were conducted meticulously to ensure compliance.
  • Change controls were implemented effectively to manage updates and revisions.
  • Printer Proof Regulatory approvals were obtained with precision and accuracy.
  • The client received comprehensive end-to-end labeling support.
  • Freyr’s team of experts delved deep into the existing labels and ensured that all the documents were compliant with the latest Regulatory requirements.
  • Updated the new company name and site address on all the labels.
  • Freyr assisted with handling initial ANDAs, SPL review activities, Change controls, printer-proof Regulatory approvals, etc.
  • Freyr provided complete support to the client, and all the labels were updated with zero queries from the health authorities.
  • Achieved 100% right-first-time submissions, ensuring accuracy and compliance.
  • Experienced zero Refuse to File instances, indicating the thoroughness of the submissions.
  • Delivered quick Turnaround Time (TAT) despite the volume of work, demonstrating efficiency and effectiveness in the process.
  • Successfully managed site transfer and name change.
  • Updated the new company name and site address on all labels.
  • Provided support for initial ANDAs, SPL review activities, change controls, printer-proof Regulatory approvals, etc.
  • All labels were ready for submission with no iterations required.