The company provides consulting and services to the pharmaceutical and medical industries, particularly in the areas of quality management, GMP consulting, cleanroom technology, validation and licensing assessments. The core activities include preparing for inspections, conducting audits, assuming pharmaceutical regulatory functions, managing manufacturing and quality control, as well as developing solution approaches for implementing quality standards.
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Industry:Management Consulting
✓ Offered8
GxP compliance consulting
Consulting for companies in the GxP-regulated environment; pragmatic solution approaches for implementing requirements and regulations, especially for pharma and medical devices.
Quality management
Quality management for implementing a wide range of GxP requirements; focused on sustainable, risk-based and practice-oriented solutions, along with support with findings.
Qualification and validation
Qualification of facilities, equipment and environmental conditions, as well as validation of processes and procedures; including requalification and computer-assisted validation.
Cleanroom and hygiene concepts
Development of user-oriented cleanroom and hygiene concepts and monitoring of planning and implementation, including in the area of contamination control.
Audits and inspections
Preparation and support for audits and inspections, as well as development of solution approaches based on findings, complemented by internal and supplier audits.
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