Clear terms for consequential work
Experienced regulatory judgment—defined scopes and clear commercial terms.
Engagement pricing depends on scope, urgency, duration, travel requirements, and expertise required.
Complex FDA matters are scoped separately
Warning Letter responses, 483 remediation, inspection support, compliance escalation, and executive quality leadership are priced based on regulatory complexity, urgency, deliverables, and the level of support required. Commercial terms are defined in the agreed scope before work begins. Every engagement begins with a 15-minute triage call.
Standard onsite consulting rate
Onsite FDA and quality advisory
Scoped onsite consulting
*2-day minimum; Day rate includes CONUS travel time; travel expenses billed at cost.
Led by a former FDA investigator and CDER compliance officer, with additional former FDA colleagues available for larger scopes. Work is scoped around the actual inspection, readiness, response, or remediation need.
Perfect For:
Mock inspections, inspection support, response strategy, remediation assessment, and other defined onsite work.
What You Get:
The agreed scope may include daily debriefs, an executive inspection summary, a mock EIR-style report, simulated Form FDA 483 observations where appropriate, and a prioritized remediation plan.
What affects the engagement scope
Number of consultants · inspection duration · urgency · remote versus onsite support · document volume · travel · specialized expertise · remediation scope
*Non-CONUS sites will need to be negotiated at separate terms.
Need to discuss confidential inspection details?
Tailwind can execute a mutual confidentiality agreement before substantive discussion of confidential regulatory or manufacturing information.