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Pharma company achieves quality and time compliant regulatory documents
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
0%
Regulatory and timeline compliance
0>%
Document review accuracy
0%↑
Business scope over 1 year engagement
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