Sponsor Successfully Completes Acquisition After Efficient PMA Submission
A major Top 10 Medical Device Sponsor engaged M2, a ProPharma Group company, to collaborate and support innovation to reduce complexity associated with a successful PMA submission.
Learn how ProPharma Group ideated and executed a creative regulatory and clinical strategy to get a novel Class III device to market using Real World Evidence (RWE).
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The Cost of Poor Project Management
Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...
Free Webinar: Effective FDA Engagement
FDA faces challenges (like new technology) and new review models (like real world evidence) that stretch agency standards and practices. At the same time, imperatives like product safety and efficacy...
Successfully Passing MHRA Inspections for Overseas Manufacturing Sites
ProPharma Group offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma Group’s Compliance and Quality team completed the...