Case Study

How To Manage A Drug Product In A Medical Device Environment

GettyImages-1248714799 audit

A global medical device company approached ProPharma to assess the setup of their entire supply chain for a drug product. We began by thoroughly reviewing their Global Quality Management System to evaluate its support for the drug product. Additionally, we conducted a comprehensive review of the entire supply chain, which spanned the United States, EU, and Switzerland, and provided detailed suggestions for improvement.

The company implemented our recommendations, which led to successful inspections by the Swiss Health Authorities (Swissmedic) and EU Health Authorities. Furthermore, ProPharma conducted over 20 audits, driving additional enhancements in their supply chain processes. Through our comprehensive assessment and ongoing support, we helped the company achieve and maintain high standards of compliance and operational excellence.

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