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Indegene

Indegene helps comply with local labeling requirements in Asia-Pacific ​

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

  • High volume of labels across 250+ product profiles​

    Too much effort to assess and compare local labels with CCDS​​

The Solution

Indegene set up an end-to-end labeling Center of Excellence (CoE) with a thorough understanding of the Asia-Pacific regulatory landscape and with local language capabilities. We oversaw label creation, updates, variation submissions, translation, and proof reading for the client. This included creation and maintenance of regional labeling documents, patient information leaflets and liaising with regional affiliates for Health Authority (HA) query resolution.

Outcomes

Indegene was able to implement the right processes and competency to address the labeling requirements for the client. We were able to clear a backlog of 1000+ labels in 2 months, manage ~6000 label change notifications and complete proofreading of 8000+ labels. As an outcome we improved accuracy, operational efficiencies and compliance for labels across their APAC product portfolio.

100%

On-time HA submissions

>99.5%

Right first-time submissions

100%

Compliance to quality guidelines

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