Zamann Pharma Support logo

Siedlerstraße 7 | 68623 Lampertheim, Germany

info@zamann-pharma.com

Digital Solutions (Computerized Systems)
Implementation and Improvements

Elevate your Pharmaceutical operations with our Digital Solutions consulting services, specializing in the fluid implementation and ongoing enhancement of digital technologies to optimize efficiency and compliance

Technology Evaluation and Selection

We conduct thorough assessments of available digital solutions in the market, considering factors such as functionality, scalability, compatibility, and cost-effectiveness. Our experts provide unbiased recommendations based on your unique needs and objectives, helping you select the most suitable technologies to drive your digital transformation initiatives.

 
 

 

 

Strategy, Validation (CSV) and Support

We offer hands-on support throughout the implementation process, providing guidance on project management, resource allocation, and change management. Our team collaborates closely with yours to ensure the smooth integration of new digital solutions into your existing infrastructure, minimizing disruptions, and maximizing adoption. We can handle all activities of Computerized System Validation, providing a compliant service aligned with all necessary regulations.

 
 

 

 

Project Management

Our consultants work closely with your organization to develop a comprehensive roadmap tailored to your specific goals and challenges. We assess current processes, identify opportunities for digital transformation, and outline a strategic plan for implementation, ensuring alignment with industry standards and regulatory requirements.

 
 

 

 

Regulatory Compliance

We ensure that all digital solutions implemented adhere to applicable regulations. Our consultants conduct thorough the Quality processes the integrity, reliability, and security of digital systems.

 
 

 

 

SOLUTION (SYSTEM) DEFINITION

COMPUTERIZED
SYSTEM VALIDATION EXECUTION

PROJECT MANAGEMENT

DIGITAL TRANSFORMATION

QUALITY COMPLIANCE

Our Customers

TÜV SÜD ISO 9001 Quality Management System certification emblem for excellence in quality assurance standards.

TÜV-certified
ISO 9001 Quality Management System

Icon representing consulting services in pharmacy and medical technology quality assurance.

Consulting service in the field of pharmacy, medical technology and quality assurance

Icon for supplier qualification services in pharmacy and medical technology sectors

Supplier qualification in the field of pharmacy, medical technology and quality assurance. 

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Personnel qualification in the field of pharmacy, medical technology and quality assurance. 

Icon illustrating customer-specific quality management system solutions

Customer-specific provision of quality management systems.

Our Services

  • Computerized Systems Validation Landscape – Implementation or Improvement

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  • Master Data Management (Computerized Systems) – Strategic Consultancy

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  • Access Management (Computerized Systems) – Strategic Consultancy

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  • Implementation of a new Computerized System – Strategic Consultancy

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  • Computerized Systems Validation Audit Readiness – Strategic Consultancy

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  • Master Data Management (Computerized Systems) – Routine Support

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  • Access Management (Computerized Systems) – Routine Support

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  • Computerized Systems Validation – Routine Support

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  • Computerized Systems Validation Audit Readiness – Routine Support

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  • Quality Management Systems Landscape – Implementation or Improvement

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  • Knowledge Management – Strategic Consultancy

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  • Non-compliance – Strategic Consultancy

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  • Change Control – Strategic Consultancy

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  • Risk Management – Strategic Consultancy

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  • Market Complaints – Strategic Consultancy

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  • Quality Management Review Support

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  • Batch Record Review – Strategic Consultancy

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  • Periodical Internal Audits – Strategic Consultancy

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    Service PDF
  • EudraLex Vol.4 Annex 1 – Strategic Consultancy

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    Service PDF
  • Project Management with Quality Focus – Strategic Consultancy

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    Service PDF
  • Quality Management Systems Audit Readiness – Strategic Consultancy

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  • Knowledge Management – Routine Support

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  • Non-compliance – Routine Support

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    Service PDF
  • Change Control – Routine Support

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  • Risk Management – Routine Support

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    Service PDF
  • Market Complaints – Routine Support

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    Service PDF
  • Batch Record Review – Routine Support

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    Service PDF
  • Periodical Internal Audits – Routine Support

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    Service PDF
  • EudraLex Vol.4 Annex 1 – Routine Support

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    Service PDF
  • Project Management with Quality Focus – Routine Support

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    Service PDF
  • Quality Management Systems Audit Readiness – Routine Support

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    Service PDF
  • Equipment Qualification – Strategic Consultancy

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  • Cleaning Validation – Strategic Consultancy

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  • Process Validation – Strategic Consultancy

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  • Water Systems Validation (WFI, PW and Pure Steam) – Strategic Consultancy

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  • Equipment Qualification – Routine Support

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    Service PDF
  • Cleaning Validation – Routine Support

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    Service PDF
  • Process Validation – Routine Support

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    Service PDF
  • Water Systems Validation (WFI, PW and Pure Steam) – Routine Support

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    Service PDF
  • Computerized Systems Validation Landscape – Strategy Definition

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  • Computerized Systems Validation Landscape – Operational Documents Creation

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  • Computerized Systems Validation Landscape – GAP Assessment

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  • Master Data Management (Computerized Systems)– Strategy Definition

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  • Master Data Management (Computerized Systems) – GAP Assessment

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  • Access Management (Computerized Systems) – Strategy Definition

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  • Access Management (Computerized Systems) – GAP Assessment

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  • New Computerized System – Support on Implementation

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  • Labware LIMS System – Implementation Support

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  • Computerized Systems Implementation – Project Management with Quality Focus

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  • Waters Empower System – Implementation Support

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  • e-QMS System – Implementation Support

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    Service PDF
  • Computerized Systems Validation Audit Readiness – Strategy Definition

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    Service PDF
  • Computerized Systems Validation Audit Readiness – GAP Assessment

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  • Master Data Management (Computerized Systems) – Audit Execution

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  • Master Data Management (Computerized Systems) – Workshop and Trainings

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  • Access Management (Computerized Systems) – Audit Execution

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  • Access Management (Computerized Systems) – Workshop and Trainings

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  • Computerized Systems Validation – Execution

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  • Computerized Systems Validation – Periodic Review Execution

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  • Computerized Systems Validation – Audit Trail Review Execution

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  • Labware LIMS System – Routine Support

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    Service PDF
  • Waters Empower System – Routine Support

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    Service PDF
  • e-QMS System – Routine Support

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    Service PDF
  • Computerized Systems Validation – Workshop and Trainings

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  • Computerized Systems Validation Audit Readiness – CAPA Plan Management

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  • Computerized Systems Validation Audit Readiness – Audit Execution

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  • Computerized Systems Validation Audit Readiness – Workshop and Trainings

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    Service PDF
  • Quality Management Systems Landscape – Strategy Definition

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    Service PDF
  • Quality Management Systems Landscape – Operational Documents Creation

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  • Quality Management Systems Landscape – GAP Assessment

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  • Knowledge Management – Strategy Definition

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  • Knowledge Management – GAP Assessment

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  • Non-compliance – Strategy Definition

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  • Non-compliance – GAP Assessment

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  • Change Control – Strategy Definition

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  • Change Control – GAP Assessment

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  • Risk Management – Strategy Definition

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  • Risk Management – GAP Assessment

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  • Market Complaints – Strategy Definition

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    Service PDF
  • Market Complaints – GAP Assessment

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    Service PDF
  • Quality Management Review – Strategy Definition

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    Service PDF
  • Quality Management Review – GAP Assessment

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    Service PDF
  • Batch Record Review – Strategy Definition

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    Service PDF
  • Batch Record Review – GAP Assessment

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    Service PDF
  • Periodical Internal Audits – Strategy Definition

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    Service PDF
  • Periodical Internal Audits – GAP Assessment

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    Service PDF
  • EudraLex Vol.4 Annex 1 – Strategy Definition

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    Service PDF
  • EudraLex Vol.4 Annex 1 – GAP Assessment

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    Service PDF
  • Project Management with Quality Focus – Strategy Creation

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  • Project Management with Quality Focus – GAP Assessment

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    Service PDF
  • QMS Audit Readiness – Strategy Definition

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  • QMS Audit Readiness – Full Program Implementation

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  • Knowledge Management – General GxP Trainings Program

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  • Knowledge Management – Focused Trainings

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  • Non-compliance – Audit Execution

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  • Non-compliance – Workshop and Trainings

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  • Change Control – Audit Execution

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  • Change Control – Workshop and Trainings

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  • Risk Management – Audit Execution

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  • Risk Management – Workshop and Trainings

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  • Market Complaints – Audit Execution

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  • Market Complaints – Workshop and Trainings

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    Service PDF
  • Batch Record Review – Execution

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    Service PDF
  • Batch Record Review – Workshop and Trainings

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    Service PDF
  • Periodical Internal Audits – Execution

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    Service PDF
  • Periodical Internal Audits – CAPA Plan Management

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  • Periodical Internal Audits – Workshop and Trainings

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    Service PDF
  • EudraLex Vol.4 Annex 1 – Project Management

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    Service PDF
  • EudraLex Vol.4 Annex 1 – Workshop and Trainings

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    Service PDF
  • Project Management with Quality Focus – Execution

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    Service PDF
  • Management of GxP Projects – Workshop and Trainings

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  • QMS Audit Readiness – GxP Audit Execution

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  • QMS Audit Readiness – Workshop and Trainings

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  • QMS Audit Readiness – CAPA Plan Management

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  • Equipment Qualification – Strategy Definition

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  • Equipment Qualification – Operational Documents Creation

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  • Equipment Qualification – GAP Assessment

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  • Cleaning Validation – Strategy Definition

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    Service PDF
  • Cleaning Validation – Operational Documents Creation

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  • Cleaning Validation – GAP Assessment

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  • Process Validation – Strategy Definition

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  • Process Validation – Operational Documents Creation

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  • Process Validation – GAP Assessment

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  • Water Systems Validation (WFI, PW and Pure Steam) – Strategy Definition

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  • Water Systems Validation (WFI, PW and Pure Steam) – Operational Documents Creation

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  • Water Systems Validation (WFI, PW and Pure Steam) – GAP Assessment

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  • Equipment Qualification – Execution

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  • Equipment Qualification – Project Management

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  • Equipment Qualification – Workshop and Trainings

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  • Cleaning Validation – Execution (Equipment and Lab Glassware)

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  • Cleaning Validation – Project Management

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  • Cleaning Validation – Workshop and Trainings

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  • Process Validation – Execution

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  • Process Validation – Project Management

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  • Process Validation – Workshop and Trainings

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  • Water Systems Validation (WFI, PW and Pure Steam) – Execution

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  • Water Systems Validation (WFI, PW and Pure Steam) – Project Management

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  • Water Systems Validation (WFI, PW and Pure Steam) – Workshop and Trainings

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  • Quality Leadership
    Development

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    Service PDF Visit Page
  • Medical Devices EU Registration – Implementation and Improvement

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    Service PDF Visit Page
  • Medical Devices EU Registration - Routine Support

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    Service PDF Visit Page
  • Nitrosamines: Compliance with requirements - Implementation and Improvement

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    Service PDF Visit Page
  • Nitrosamines: Compliance with requirements - Routine Support

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  • Safe use of AI tools in Quality: Data Security and Process Optimization

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  • Quality Leadership Development – Competency Development Program

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  • Medical Device EU Registration – Strategic Consultancy

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  • Medical Device EU Registration – Routine Support

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  • Nitrosamines – Strategic Consultancy

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  • Nitrosamines – Routine Support

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    Service PDF
  • Quality Leadership Development – Competency Evaluation

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  • Quality Leadership Development – Development Plan Creation

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  • Medical Device EU Registration – Strategy Definition

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  • Medical Device EU Registration – Operational Documents Creation

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  • Medical Device EU Registration – GAP Assessment

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  • Medical Device EU Registration – Execution

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  • Medical Device EU Registration – Project Management

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  • Medical Device EU Registration – Workshop and Trainings

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  • Nitrosamines – Strategy Definition

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  • Nitrosamines – Data Management Strategy Creation

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  • Nitrosamines – Drug Product Risk Management Strategy Creation

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  • Nitrosamines – Drug Substance Risk Management Strategy Creation (for NDSRI)

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  • Nitrosamines – GAP Assessment regarding ICH M7

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  • Nitrosamines – Analytical Strategy Creation

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  • Nitrosamines – Data Management Activities Execution

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  • Nitrosamines – Risk Assessment Creation

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  • Nitrosamines – Workshop and Trainings

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  • Nitrosamines – Project Management

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  • Nitrosamines – QMS Life Cycle Integration

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