End-to-end, post-market surveillance complaint handling and regulatory reporting support for a US-based medical device manufacturer
February | 2021
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
Solution
Business Impact
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© 2021 Wipro Limited |
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© 2021 Wipro Limited |
Pharmaceutical & Life Sciences