We are your experts for regulatory matters.
QVA and GMP compliance
Qualification and validation (QVA): the key to product quality
Customised QVA strategies
Our experts develop customised qualification and validation strategies that are perfectly tailored to your specific requirements.
We take this into account:
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Current international regulations
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Industry-specific best practices
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Your company goals and resources
Risk-based QVA approach
Comprehensive QVA services
Our interdisciplinary team offers you a wide range of QVA services:
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Plant qualification
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process validation
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Cleaning validation
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Computer validation
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Media validation
We implement a risk-based approach in accordance with ICH Q9 in order to:
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Allocate resources efficiently
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Identify critical control points
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Prioritise validation activities
GMP compliance: Your competitive advantage
Holistic GMP consulting
Implementation and optimisation of quality management systems (QMS)
Our GMP compliance consulting accompanies you through all phases of the product life cycle:
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Conception and planning
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Development and scale-up
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Production and quality control
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Storage and distribution
Preparation for inspections by authorities
We support you with the introduction or improvement of your QMS:
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Gap analysis of existing systems
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Development of GMP-compliant SOPs and guidelines
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Training and sensitisation of employees
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Continuous improvement processes
Our experts prepare you optimally for inspections:
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Carrying out mock inspections
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Training staff in inspection behaviour
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Creation of complete documentation packages
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Follow-up and implementation of improvement measures
Our added value for your success
01
Cross-industry expertise
With our many years of experience in the pharmaceutical and biotech industry, we understand the specific challenges facing your company.
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Customised solutions
We adapt our services flexibly to your individual needs - whether you are a large corporation or an innovative start-up.
03
Current regulatory expertise
Our team always keeps up to date with the latest developments in the areas of FDA, EMA, ICH and PIC/S.
04
Efficiency and cost optimisation
Our risk-based approach and many years of experience enable us to optimise your processes and reduce your compliance costs.
