Pharma company achieves quality and time compliant regulatory documents

The Customer

A leading global biopharmaceutical company focused on human healthcare and research with a large product portfolio (innovator, prescription, over the counter, etc.) covering major therapy areas including vaccines.

Challenges

Capacity constraints due to rapidly increasing portfolio including drugs, biologics and consumer healthcare (CHC) products
Low compliance to quality in submissions and multiple review cycles leading to extended timelines

The Solution

Indegene deployed a dedicated CoE consisting of Program Manager, Medical Reviewer, Medical writer, Medical Editor and Publishing associate. The team coordinated contributions, compilation of safety and non safety sections, document QC, formatting and handover of finalized documents. We improvised deliverable quality control by ensuring client SOP compliance, consistency and completeness of information, language, correlation and cross references between document components. The team also supported document/report level publishing activities.

Outcomes

Indegene was able to streamline capacity management around regulatory writing requirements and drive efficiencies for the client, especially with the rapidly increasing product portfolio of the client

We were able to enable timely submissions while ensuring compliance to regulatory requirements

100%

Regulatory and timeline compliance

>95%

Document review accuracy

100%↑

Business scope over 1 year engagement

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Pharma company achieves quality and time compliant regulatory documents ​