Teams with a defined outcome (e.g., document review, 2-day onsite audit, CAPA verification).

Larger initiatives with clear workstreams (e.g., cleanroom build-out, SOP suite, equipment qualification/validation, remediation).

Fixed scope and milestones

A dedicated lead consultant plus specialists as needed

Project plan with ongoing progress updates

Final deliverables (reports, protocols, executed records, training, etc.)

Small/quick: Targeted document review, gap analysis, audit & report (2 days onsite + write-up).

Medium: SOP library authoring/revision, media fill & aseptic simulations, cleaning validation.

Large: New cleanroom start-up, end-to-end 503B readiness, equipment URS→IQ/OQ/PQ.

Budget set by scope; hours are allocated to workstreams.

Scaled discounts apply for larger/longer packages.

Change control in writing for any scope adds.