Supplier and OSP categorization
Risk-based categories for component suppliers, assembly, labeling, and packaging operations, contract laboratories, and outsourced service providers.
Combinate BioWorks
Combination product purchasing and supplier controls.
Align drug and device supplier requirements while defining how component suppliers, assembly, labeling, and packaging sites, laboratories, and outsourced service providers are categorized, selected, qualified, controlled, and monitored.
One purchasing framework.
Combination product organizations often inherit separate pharmaceutical and device supplier-quality processes. The work defines what applies to each supplier category, aligns ownership across the drug and device teams, and creates a practical framework the organization can operate.
Supplier selection and qualification
Selection criteria, due diligence, risk assessment, audit expectations, approval pathways, and required records.
Purchasing controls procedures
Combination product purchasing controls SOPs, workflows, and interfaces with existing pharmaceutical and device supplier systems.
Quality agreements
QAG templates and responsibility matrices covering notification, change, investigation, CAPA, escalation, and oversight.
Drug-device team alignment
Roles, decision rights, and handoffs across pharmaceutical supplier quality, device quality, procurement, technical operations, and external manufacturing.
Lifecycle oversight
Performance monitoring, periodic review, supplier changes, requalification, issue escalation, and remediation follow-through.
Work can focus on one partner, a supplier network, or the broader oversight system. Audits may be included. Final supplier approval, quality decisions, and operational ownership remain with the client.