Combination product consulting.
Built for the interfaces.
Start where the work gets complicated.
Quality Systems & Governance
Clarify how drug and device quality systems fit together, who owns the interfaces, and where the gaps sit.Interface assessment · responsibility matrix · roadmap
QMSR Assessment & Training
Understand the effect of QMSR on your quality system and translate the gaps into a defined action plan.Gap assessment · action priorities · team workshop
Audits & Inspection Readiness
Evaluate the system, follow the evidence, and turn audit observations into useful priorities.Audit plan · evidence-based report · readiness priorities
Purchasing & Supplier Controls
Align combination product purchasing requirements, supplier categories, qualification, and oversight across drug and device quality systems.Categorization framework · purchasing controls SOP · QAG templates
Design Controls & Lifecycle Quality
Connect requirements, risk, verification and validation, control plans, transfer, and change across the combination product lifecycle.Design-controls assessment · control strategy · lifecycle framework
First-in-Human & Clinical Quality Support
Prepare early clinical programs with clear quality priorities, partner oversight, and responsibilities.Readiness assessment · quality plan · partner coordination
Let’s define the work.
Tell us what your team needs to improve.