Case Study: Regulatory Publishing

Background – Client Needs:

A US based top 10 global pharmaceutical company was looking for End to End processing of submission ready documents to accelerate the process of submission in the US market.

Challenges Faced by the Client:

  • Continuous production of regulatory submission packages to United States market
  • Life cycle management of already approved products in the US market

  • Resources and cost for processing of submission ready documents

Project Initiation & Key Objectives:

The client was looking for long-term partnership with a regulatory service provider for a full-service solution with minimal oversight. The key focus of the partnership was to achieve productivity and cost advantages with excellent quality and risk management.

Celegence was awarded a multi-year contract to help this customer with the business process related activities, including process definition & execution of the following activities:

  • Electronic Quality Check (eQC) and End-to-End 1572 Submissions of a broad spectrum of products

  • A blended business model with onshore resources and CoE in Bangalore to execute the activities as per the scope of the project

  • A highly secure work environment in the client’s databases through secure virtual private networks which mimics our data privacy policies

  • Effective submission strategy through experienced project manager and team leads to ensure high quality outputs

  • Robust quality management model with defined QC gates by SMEs

Key Project Achievements:

  • Defined the end-to-end process for Submission ready documents (Publishing related activities)

  • > 98% quality of outputs of the Submission Ready Documents

  • Organized review of Submission output before submitting to the Health Authorities

  • > 98% turnover of all 1572 submissions for the life cycle management of client products in the US market

  • 100% turnover time and timeline compliance of all activities related to submission ready documents

  • The end-to-end approach defined by Celegence has resulted in significant learnings and business process improvements within the organization.

  • Highly efficient business model that reflects round the clock turn around for submission ready documents

Business Impact:

  • > 40% efficiency of client’s resources through a blended resourcing model of varied experience in the US & CoE in India

  • 100% turnaround time has resulted in effective lifecycle management and timely approvals and/or renewals in the US market

  • This collaborative partnership for eQC processing and 1572 submissions has a notable impact on the cost for the client through reduction of resources and high timeline compliance with quality (reduced rework)

Find out more information about Celegence’s Regulatory Publishing capabilities

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