• gempex China Ltd. CN/EN
  • gempex GmbH DE/EN
400-166-2002

Cases

Cases

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.

Typical Cases

    Global Market Expansion
    • Sponsor or MAH Qualification
    • QP Service
    Inspection Readiness
    • GAP analysis
    • Upgrade and Coaching
    • Mock Inspection
    • Inspection Guidance
    • Post Inspection Support
    Facilities Validation
    • Facilities Concept
    • Design Drawing Review
    • Qualification and Validation concept
    • Commissioning and qualification Execution
    • Validation Support
    Quality Management
    • QMS Establishment
    • QMS Optimization
    • Outsourced QA Office
    • Risk Management or CCS
    • Statistics Application
    CS&AI Compliance
    • CS Management System
    • CS Validation
    • IT Infra Qualification
    • Data Integrity
    • AI Concept and Compliance
    More Consulting
    • Regulatory Briefing
    • 2nd or 3rd Party Audit
    • Training and Workshop
    • Technology Transfer

Typical Cases

    Global Market Expansion
    • Sponsor or MAH Qualification
    • QP Service
    Inspection Readiness
    • GAP analysis
    • Upgrade and Coaching
    • Mock Inspection
    • Inspection Guidance
    • Post Inspection Support
    Facilities Validation
    • Facilities Concept
    • Design Drawing Review
    • Qualification and Validation concept
    • Commissioning and qualification Execution
    • Validation Support
    Quality Management
    • QMS Establishment
    • QMS Optimization
    • Outsourced QA Office
    • Risk Management or CCS
    • Statistics Application
    CS&AI Compliance
    • CS Management System
    • CS Validation
    • IT Infra Qualification
    • Data Integrity
    • AI Concept and Compliance
    More Consulting
    • Regulatory Briefing
    • 2nd or 3rd Party Audit
    • Training and Workshop
    • Technology Transfer

Reference

Evonik Operations GmbH

gempex provided Evonik to qualify suppliers in order to maintain compliance requirements.

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BASF SE

Review and Adaptation of the Zone Concept for Active Substance and Auxiliary Material Filling Areas.

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K+S AG

US FDA Inspection Readiness and Inspection Support

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Coperion K-Tron (Schwitzerland) LLC

Individually tailored GMP training for pharmaceutical conveyor equipment manufacturer

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Topwell Apotheke Dr. Kreyenbühl

Improvement of the GMP processes and upkeep of the production license for pharmaceutical products in small quantities

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Medicom Pharma GmbH

QM System Upgrade, Inspection Readiness, Training and long-term GDP Compliance Consulting.

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IBR Inc.

GMP Upgrade for obtaining an official GMP certificate by Swissmedic.

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DR. KADE Pharmazeutische Fabrik

Inspection Readiness for the Production of Pharmaceutical Ointments and Creams – Preparation for Inspection by the Russian Health Authorities (MIT).

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CureVac

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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b+b

Validation package for serialisation software, IT validation documents for software solutions.

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United Pharma Partners

Inspection readiness and many years of GDP consultancy as lead consultant.

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BrüggemannAlcohol Heilbronn GmbH

Comprehensive GMP Upgrade for obtaining an official GMP certificate.

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Saint-Gobain Performance Plastics Corporation

Plant relocation, new cleaning room, verification and qualification.

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