#FutureReadyHealthcare
Indegene sets up material review function for specialty biotech about to launch
The Customer
With multiple injectable products at late stages of development pipeline, and no prior experience with commercialization, the client sought to establish an material review organization that can scale with asset volumes (projected to grow 4X in the coming quarters) and remain compliant with stringent US and EU regulations
Challenges
Internal audit showed major lapses in initial efforts to create a review function, with key compliance requirements and missing audit trail
Without Standard Operating Procedures (SoPs) and training in place, the leadership team felt that its time was being wasted in firefighting issues and coordinating content activities
Emails, share drives, and other work arounds that were being used for reviews were proving too cumbersome to manage and keep track of workflow
The Solution
Foundational documents to support brand messaging-created through an understanding of content needs to support launch
SoPs, guidelines and job artifacts-created for various roles considering medical lexicon, scientific/clinical supporting data, and review requirements for brands and local markets
Selection of review platform tool and service provider by evaluating various market offerings and matching them for client needs
Outcomes
The client was able to bring products to market and scale the asset volumes by 4× using robust processes set up by Indegene