Combinate BioWorks
Combination product quality systems.
Connected across drug and device.
Make the quality system work across functions. Assess the drug and device interfaces, clarify responsibilities, and give your team a practical path forward.
When the individual systems work, but the interfaces don’t.
A combination product program can have capable teams and established procedures while still struggling with handoffs. The assessment looks at how decisions, records, and responsibilities move between drug and device functions.
- Drug and device teams interpret quality ownership differently.
- Global and site processes overlap, with unclear decision rights.
- A new product or partner introduces responsibilities that the existing system doesn’t address.
The engagement can define quality-system architecture and a governance model. Procedure writing and ongoing operational ownership are separate scopes.
Related services.
Led by Subhi Saadeh, CQA, CQE.
Meet the founder