Retained GMP Services &
Regulatory Remediation
Audit → Findings → QMS → Recovery → Release
Retained GMP Services &
Regulatory Remediation
Audit → Findings → QMS → Recovery → Release
Need urgent GMP support for inspections, remediation, or licensing gaps?
We deliver rapid, regulator-facing support—whether you're under inspection, remediating findings, or stabilizing after quality system issues.
Retained GMP Services &
Regulatory Remediation—On Standby
Audit → Findings → QMS → Recovery → Release
Retained GMP Services &
Regulatory Remediation—On Standby
Audit → Findings → QMS → Recovery → Release
Need urgent GMP support for inspections, remediation, or licensing gaps?
We deliver rapid, regulator-facing support—whether you're under inspection, remediating findings, or stabilizing after quality system failure.
What We Do:
Regulatory remediation across FDA, EMA, MOHAP, and EDE—covering inspection findings, warning letters, licensing delays, and import/export restrictions
QMS rebuilds: SOPs, CAPA, deviations, change controls, data integrity
Inspection readiness for audits, license renewal, or new market entry
Interim QP / RP services to maintain market access and batch release continuity
Post-M&A GMP gap closure for investor-backed assets or CDMO integrations
Batch release, distribution support, and technical due diligence
Our model:
Personally led by PJ Murphy, deployed globally from Dubai within 24–48 hours.
Who This Is For:
This service is ideal if you are:
A GMP-regulated site facing inspection, audit findings, or license issues
A CDMO, biotech, or pharma company with active or emerging compliance issues
A GMP strategy firm or PMO lacking GMP execution capability
A private equity firm managing post-acquisition remediation or turnaround
A quality leader or QP needing surge capacity or interim cover
A distributor or MAH struggling with licensing, batch release, or deviation control
What You Avoid:
Delays in resolving regulatory findings
Underqualified short-term contractors with no regulatory accountability
Repeat inspections, sanctions, or prolonged license risk
Gaps in QP/RP coverage that stall batch release or market access
Fragmented handovers between operations, quality, and leadership
Need support with CQV, QC backlogs, or supplier audits?
Ready to Stabilize, Recover, and Pass Inspection?
Get senior GMP support—on your side, within days.
Available on retainer or for immediate deployment—always regulator-facing, always accountable.