Case Studies
Accelerated Global Safety Database Implementation
A mid-sized U.S.-based pharmaceutical company approached Vigilare to rapidly implement a global safety database within an aggressive four-week timeline. The…
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Pharmacovigilance Quality Assurance & Compliance Auditing
A Top 10 Global Biopharmaceutical Company faced increasing regulatory scrutiny and needed to strengthen its Pharmacovigilance (PV) quality systems worldwide.…
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Medical Device Submissions & Market Registrations
A global medical device manufacturer needed to expand into multiple new markets across Europe, Middle East, and Asia-Pacific (EMEA &…
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ANDA Dossier Preparation & U.S. FDA Submission Support
An Asia-based mid-sized pharmaceutical company sought to launch a generic anti-hypertensive drug in the U.S. market. With limited internal expertise…
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