Consultation & Advisory
Senior GxP judgement,on demand.
Sometimes you don't need a full program — you need the right call, fast. Bring us in for a review, a remediation roadmap or a few days a month of validation leadership.
How we help
Advisory that moves the needle
Fractional QA & validation lead
Senior validation and quality expertise on retainer — a few days a month to steer your program without a full-time hire.
Data integrity remediation
A prioritized roadmap out of an ALCOA+ or audit finding, with the practical sequence to close gaps across paper and electronic records.
GAMP 5 / CSA strategy
Right-size your validation approach: where critical thinking and CSA lighten the load, and where full CSV rigor still earns its keep.
Inspection-readiness coaching
Mock audits, story-lines and SME prep so your team walks an FDA, EMA or CDSCO inspector through the record with confidence.
Supplier & vendor assessment
Structured audits of software vendors and service providers, with leveraged documentation that reduces your own validation effort.
SOP & policy authoring
Procedures and policies written to be followed — clear enough for the floor, defensible enough for the inspector.
Engagement models
Engage us the way that fits
Hourly advisory
Two-hour blocks for a specific question or review.
Monthly retainer
Fractional QA / validation lead, fixed days per month.
Fixed-scope project
A named deliverable with a firm price and timeline.
Next step
Want a second opinion?
The first consultation is free. Describe the situation and we will tell you whether it needs two hours or a full program.