Professional Project Management for GxP Life Science
cube one GmbH is your partner for complex validation projects. As a GxP life science partner, we support you with comprehensive project management throughout the entire development and production cycle of your chemical substances and pharmaceuticals. Our experienced team accompanies you from planning to successful implementation – so you can approach audit situations with confidence. With years of experience in the life science industry, we understand the unique challenges of regulated environments and combine proven project management methods with industry-specific expertise.
Our Project Management Services:
- Agile Project Management: Flexible and iterative project implementation following Scrum and Kanban for rapid adaptation to changing requirements – even in regulated environments.
- Traditional Project Management: Structured approach following established standards for complex validation projects with clear milestones and documentation requirements.
- Program Management: Coordination of multiple interdependent projects to achieve strategic business objectives in your GxP environment.
- Change Control Management: Professional management and documentation of changes in validated systems while maintaining regulatory compliance.
- Project Consulting: Strategic consulting for optimal project setup, risk analysis, and methodology selection for maximum project success.
- PMO Support: Establishment and support of your Project Management Office with standards, templates, and best practices for the life science industry.
Your Advantages:
- Experienced project managers with comprehensive GxP expertise
- Deep understanding of regulatory requirements (FDA, EMA)
- Proven methodologies for validation-required projects
- Flexible scaling according to your needs
- Transparent communication and clear documentation
- Integration into existing quality management systems
- Audit-proof project execution
Our Methods and Tools:
1. Project Management Frameworks
- Traditional Waterfall Model (for regulated projects)
- V-Model for validation projects
2. Project Phases
- Project initiation and stakeholder analysis
- Requirements engineering and requirements management
- Project planning and resource allocation
- Risk management and quality assurance
- Project control and monitoring
- Change management and change control
- Project closure and lessons learned
To give you better insight into our work and expertise, view some selected reference projects now.
Contact us today for personalized consultation on project management.
