Combination Products Device Specialists partner with Pharmaceutical companies by delivering lean specialist services for your specific needs. Our service scope originates from EU expertise and covers global Quality System requirements in combination with EU MDR device submissions.
Based on our regulatory and systems experience we have developed a suite of services (trainings, workshops and assessments) that transfer knowledge to your organization for making good lean transition choices (if needed..).
Now is the right time to work on the future harmonized lean state, let us help you.
The FDA QMSR will bring global harmonization to the ultimate next level. One system will satisfy World Wide Quality Management System design, including its harmonized risk management approach for combination product Pharma companies. Expected to be stable for decades.
Especially for Pharma companies oversimplification (as we today often see) of the QMSR change is quite riskful….. The QMSR is namely a full lean process based standard with risk management for process and product during the complete product lifecycle.
With robust lean systems (proven successful design-control (QbD), Production and Submission methods) you truly can enjoy peace of mind for any future inspection.
Contact us to discuss the full suite of services, for your lean success.
PS: Wir Sprechen Deutsch, sicher so angenehm!