Combinate BioWorks
Combination product lifecycle quality.
Keep the handoffs connected.
Quality advisory support at the interfaces between design and development, risk management, transfer, manufacturing, and lifecycle change.
The next phase needs more than a handoff meeting.
Development and commercial teams can work to different assumptions about evidence, responsibilities, and change. A focused review makes those assumptions visible and helps define how the quality interfaces should work.
- Design-control responsibilities cross drug and device functions.
- Transfer activities lack clear quality ownership or acceptance criteria.
- Changes need coordinated assessment across constituent parts and partners.
This service is quality advisory and assessment work. Engineering design, verification or validation execution, and submission authorship are not included.
Related services.
Led by Subhi Saadeh, CQA, CQE.
Meet the founder