In today’s pharmaceutical ecosystem, pharmacovigilance (PV) has become more global, modular, and digitally enabled than ever before. Sponsors now rely on extended vendor networks CROs, BPOs, cloud technology partners, and niche safety-service providers. While these
Read MoreAn Asia-based mid-sized pharmaceutical company sought to launch a generic anti-hypertensive drug in the U.S. market. With limited internal expertise in FDA submissions and facing a tight launch timeline, the client needed end-to-end support for
Read MoreA global medical device manufacturer needed to expand into multiple new markets across Europe, Middle East, and Asia-Pacific (EMEA & APAC). The challenge was to achieve quick and compliant registration of Class II and III
Read MoreA Top 10 Global Biopharmaceutical Company faced increasing regulatory scrutiny and needed to strengthen its Pharmacovigilance (PV) quality systems worldwide. The project included 15+ global PV audits across 9 months, addressing inconsistent PV practices across
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