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Indegene fast-tracks the remediation and delivery of 1000+ DHF documentations

The Customer

A leading designer and manufacturer of injectable pharmaceutical packaging and delivery systems headquartered in the US, committed to high quality, service, and innovation.


  • Stringent regulations coupled with evolving product iterations leading to incomplete product design documentation (DHF) thus resulting in critical regulatory findings

    Delays in regulatory approval in turn impacting customer’s partners' operations​

    Deficiency and gaps in DHF documentation leading to repeat design verification and validation activities that can cost time and effort and again delay regulatory approvals

    Chaotic and unorganized DHF leading to difficulties in managing product changes and design traceability

Indegene Solution

Indegene established a dedicated centre of excellence (COE) of highly skilled quality professionals with expertise in medical device specific design controls and DHF management to perform a detailed gap analysis and execute the project

Indegene validated supplier inputs like drawings, reference data etc with a data-driven approach while working with a large number of customer's suppliers

Collaborative customer stakeholder coordination to complete documentation on time with subject matter experts to ensure alignment to the latest regulations and customer requirements

End-to-end program management with usage of templates, checklists, first-time right metrics, etc.



First Draft acceptance


Quality, compliance, and timelines


Increased productivity