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We highly value the trust of our customers and have completed more than 5000 GMP projects. gempex customers are companies in the pharmaceutical, biotechnology, chemical, API, medical devices, raw and material package, cosmetic and other industries as well as their suppliers. A selection of references in cooperation with our customers follows.
A client needed to establish a quality management system compliant with China's MAH regulatory framework. gempex tailored the system documentation to their specific needs. As a result, the client successfully obtained a Drug Manufacturing License (Type B) within eight months.
Service support:
1.Provide GMP consultancy
2.MAH QMS establishment
3.Training&Compliance Guide
4.Support on Production License application
5.QMS Maintain
6.Guide and support on on-site inspection
A client needed to establish a quality management system compliant with China's MAH regulatory framework. gempex tailored the system documentation to their specific needs. As a result, the client successfully obtained a Drug Manufacturing License (Type B) within eight months.
Service support:
1.Provide GMP consultancy
2.MAH QMS establishment
3.Training&Compliance Guide
4.Support on Production License application
5.QMS Maintain
6.Guide and support on on-site inspection
A client needed to establish a quality management system compliant with China's MAH regulatory framework. gempex tailored the system documentation to their specific needs. As a result, the client successfully obtained a Drug Manufacturing License (Type B) within eight months.
Service support:
1.Provide GMP consultancy
2.MAH QMS establishment
3.Training&Compliance Guide
4.Support on Production License application
5.QMS Maintain
6.Guide and support on on-site inspection
A client needed to establish a quality management system compliant with China's MAH regulatory framework. gempex tailored the system documentation to their specific needs. As a result, the client successfully obtained a Drug Manufacturing License (Type B) within eight months.
Service support:
1.Provide GMP consultancy
2.MAH QMS establishment
3.Training&Compliance Guide
4.Support on Production License application
5.QMS Maintain
6.Guide and support on on-site inspection
A client needed to establish a quality management system compliant with China's MAH regulatory framework. gempex tailored the system documentation to their specific needs. As a result, the client successfully obtained a Drug Manufacturing License (Type B) within eight months.
Service support:
1.Provide GMP consultancy
2.MAH QMS establishment
3.Training&Compliance Guide
4.Support on Production License application
5.QMS Maintain
6.Guide and support on on-site inspection
A client needed to establish a quality management system compliant with China's MAH regulatory framework. gempex tailored the system documentation to their specific needs. As a result, the client successfully obtained a Drug Manufacturing License (Type B) within eight months.
Service support:
1.Provide GMP consultancy
2.MAH QMS establishment
3.Training&Compliance Guide
4.Support on Production License application
5.QMS Maintain
6.Guide and support on on-site inspection
gempex provided Evonik to qualify suppliers in order to maintain compliance requirements.
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Review and Adaptation of the Zone Concept for Active Substance and Auxiliary Material Filling Areas.
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US FDA Inspection Readiness and Inspection Support
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Individually tailored GMP training for pharmaceutical conveyor equipment manufacturer
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Improvement of the GMP processes and upkeep of the production license for pharmaceutical products in small quantities
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QM System Upgrade, Inspection Readiness, Training and long-term GDP Compliance Consulting.
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GMP Upgrade for obtaining an official GMP certificate by Swissmedic.
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Inspection Readiness for the Production of Pharmaceutical Ointments and Creams – Preparation for Inspection by the Russian Health Authorities (MIT).
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Continuous, broad technical support in various projects as GMP expert and project manager in the service fields of qua- lity control, project management, qualification, validation and routine GMP operation.
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Validation package for serialisation software, IT validation documents for software solutions.
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Inspection readiness and many years of GDP consultancy as lead consultant.
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Comprehensive GMP Upgrade for obtaining an official GMP certificate.
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Plant relocation, new cleaning room, verification and qualification.
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