Regulatory Publishing

Project Summary

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

Celegence Solution & Approach:

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:

Highlights:

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