Risk analysis for pharma and biotech
Your entire project stands or falls with a risk analysis.
Our services in the area of risk analysis
Effective risk management is essential in the highly regulated and innovative pharmaceutical and biotech industry. Our customised risk analyses help you to proactively meet challenges and continuously improve the quality of your products and processes.
Why risk analyses in pharma and biotech?
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Fulfilment of regulatory requirements (EU GMP Guideline Part 3, ICH Q9)
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Early detection of potential problems
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Optimisation of resources and costs
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Increasing product quality and safety
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Promotion of a deeper understanding of processes
Our approach: efficient, practical and compliant
Analysing your requirements: We understand your specific processes and regulatory challenges.
Customised methodology: We select the right tools and approaches for your individual needs.
Practical results: We deliver realisable findings and concrete recommendations for action.
Interdisciplinary collaboration: We bring all relevant stakeholders to the table.
Sustainable integration: We support you in embedding the results in your quality management system.
Your added value through our risk analyses
01
Compliance Security
Fulfilment of all relevant GMP requirements.
02
Cost efficiency
Targeted allocation of resources by prioritising risks.
03
Knowledge gain
Deeper understanding of your processes and systems.
04
Decision support
Sound basis for strategic and operational decisions.
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Continuous improvement
Establishing a culture of proactive risk management.
