CQV advisory · Pharma & biotech
Compliant Professionals LLC provides senior CQV guidance for facilities, utilities, and GMP equipment. Protocol authorship, C&Q execution oversight, and project leadership under cGMP—available on a selective, fractional basis.
Focused support where experienced CQV judgment matters most. Engagements are scoped to the work—not sold as headcount.
Strategy and technical direction for commissioning, qualification, and validation programs. Facilities, utilities, and GMP equipment—aligned to your quality system and project phase.
From $1,575 · fixed scope · ~10 business days
One equipment class: tailored IQ + OQ templates, execution checklist, open-point log stub, 90-minute review call, and one revision pass—without a full-time CQV hire.
Targeted sessions for stuck decisions, document gaps, or leadership that needs a second set of senior eyes.
Compliant Professionals LLC is the independent practice of James Gaines, a CQV professional focused on pharma and biotech environments.
Work centers on practical delivery: protocols that can be executed on the floor, qualification that stands up to scrutiny, and project leadership that respects both schedule and compliance.
James also works onsite at Bespoke Pharmaceutical in Las Vegas most of the week. External engagements are therefore selective—fractional, advisory, and project-scoped rather than full-time staffing.
Straightforward engagement. Clear scope. Direct communication.
Brief call or email on the system, phase, and what “done” looks like—protocols, advisory hours, or leadership support.
Written scope, deliverables, and timeline that fit selective availability. No open-ended staffing promises.
Work is delivered as agreed—reviewed documents, advisory input, or on-project leadership—then closed cleanly.
If you have a CQV need that fits fractional or project-based support, reach out directly. Availability is limited; replies are personal.
gainesj@compliantprofessionals.org