What we do…
The Hollis Group helps Life Sciences organizations improve quality, compliance, operations, logistics, information and financial performance of their clinical trial support operations through the effective use of information technology. We specialize in working with small-to-medium businesses, from start-ups through successful exits in pharmaceuticals, biotech and medical devices, focusing on the downstream research operations of manufacturing, supply and logistics.
Life Sciences Quality and Compliance…
• Quality Management System Design, Development and Deployment
• Cross-Agency (FDA, MHRA, HC-SC, EMA) Regulatory Compliance
• Audit and Design of On-site and Supplier Quality Management Systems
Life Sciences Operations and Logistics…
• Clinical Manufacturing Operations and Packaging Systems
• Automated Materials Warehouse and Logistics Management Systems
• Experience with Non-Standard Inventory, Including Returns and Recalls
Life Sciences Industry Infrastructure…
• Validation and Qualification to Regulatory Standards (21CFR11, Annex 11)
• Security Design and Audit of Computer and Network Infrastructure
• Systems Development Lifecycle Training, Audit and Project Oversight