End-to-end, post-market surveillance complaint handling and regulatory reporting support for a US-based medical device manufacturer

Type of products covered: medical devices, therapeutic drugs, and compounding/ biological products.

Processes owned: performing multilingual intake/data entry, triage, complaints investigation, regulatory assessment/decision (US/OUS), regulatory reporting and direct submission (US/OUS), good faith efforts, and complaints closure.

Number of products: supporting 200+ product families across the geography.

Client Background

A Fortune 500 company generating a revenue of over $10 billion. The Company primarily focuses on products to treat hemophilia, kidney disease, immune disorders, and other chronic and acute medical conditions.

Challenge

Lack of a standardized process which introduced a variance in learning ("tribal knowledge") or knowledge gap.
Lack of procedural standardization.

Solution

Provided cost efficiency with resource optimization and efficiency gain over a five year engagement, leveraging labor arbitrage, process interoperability, role streamlining, and cross-skilling.
Process transformation and standardization: close collaboration with customers on procedural updates and documentation. Bringing in best practices amplified in synergy with Wipro's in-house solutions and quality excellence initiatives.

Business Impact

Standardization of process and procedures.
Saving of $3.3 million, equivalent to 20 full time equivalent (FTE) benefit to the client’s business value meter (BVM), over a five year period.

“This is a story of consistent growth, improved quality outcomes, consistent performance, flexibility, proven scalability, and a highly responsive team.”

Service Offerings

Service Offerings

Client Themes

Client Themes

End-to-end, post-market surveillance complaint handling and regulatory reporting support for a US-based medical device manufacturer.

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