Navigating QMS Requirements from a Medical Device Perspective

Having a different number of pharmaceutical classified products in your portfolio provides a challenge in EU. As distribution and sales of MD products are under MDR, while pharmaceuticals are under EU-GDP and require a wholesaler dealer authorization (WDA). By efficient support from our QA consultant, the client was able to update their QMS and meet current GDP requirements.

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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...

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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...

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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...