Pharma Compliance

Yor contact person: Dr. Georg Sindelar

Chemgineering will support you in all aspects of GMP and Compliance with experienced experts and specialists from industry and regulatory bodies. Within our Life Cycle Management for Quality Systems we can support you in designing a modern Quality System or a single Quality Module like risk management. Of course we also help with the implementation at the site. Using established Mock-Audit approaches we check and evaluate your systems prior to authority inspections. We help with set-up and implementation of CAPAs from QC-lab to (continued) process validation and guide you through the inspection, whether local or e.g. by FDA. In any case of bottlenecks, be it subject matter specific or simply due to work load, we can support you with specialists for subjects like sterile production, GDP, PiP or interim management. The performance of your supplier qualification as 3rd party auditors completes our service portfolio.

Q-Systems Design

For pharmaceutical quality systems, the requirements of regulatory bodies on the one hand but also of company management on the other hand have significantly changed in recent years.

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Q-Systems Implementation

Even well-designed quality systems have yet to be implemented and internalized.

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Q-Systems Inspection

The FDA is knocking at your door? The local regulatory body inspection has been announced?

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Q-Systems Management Support

Your systems are running fine, in general. However, some important subjects will always drop out due to lack of time.

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Our Experts

Há Sempre Um Jeito!

Das kommt aus dem brasilianischen und bedeutet: Es gibt immer einen Weg.

Sie suchen nicht irgendeinen Weg. Sie suchen einen guten Weg. Dafür benötigen Sie Erfahrung und Arbeitskraft.

Und so wie es für jedes Problem eine gute Lösung gibt, haben wir für Ihre Probleme die richtigen Leute.

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Our Philosophy

Jedes Qualitätsmanagementsystem wird von Menschen mit Leben gefüllt. Wir begleiten Sie. Unsere Lösungen sind auf Sie abgestimmt. Und kommen von Mensch zu Mensch. Für jede Phase Ihrer betrieblichen Situation suchen wir mit Ihnen zusammen nach einer Lösung.

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Chemgineering Business Design AG | Binningerstrasse 2 | 4142 Münchenstein | T +41 61 467 89 00 | F +41 61 467 89 01 | www.chemgineering.com | info@chemgineering.com