Operations & Technology
Operational and technological aspects of IMP management consulting we cover:
- IMP Project Management
- Introduction of efficient methodologies and taking over project management activities to free up your resources, specifically of outsourced projects
- Take over of the entire IMP supply chain for individual studies or entire projects
- Auditing of contract manufacturers
- Inspections: preparation and MOCK Inspections
- Documentation
- Establishment of SOPs, RFPs, User Requirement Specifications for IVRS/IWRS and MES, and Product Specification Files
- Review of batch documentation
- Conduction of User Acceptance Tests for IVRS/IWRS and MES
- Technological Aspects, e.g.:
- Randomisation & Labelling / Barcode controlled Labelling Systems
- Inventory Management & Distribution
- MES and IVRS/IWRS in IMP management
- Automation in IMP packaging
- Value opportunity assessments (equipment, software, facilities, sites)
- Technology Transfers
Project References