2040 Consulting
Pharma and Life-Sciences Facility Builds & GMP
Builds, Licenses & Defends Regulated Pharma Facilities
Expertise in navigating regulatory requirements of global authorities (e.g., ICH, US FDA, EMA) and the Emirates Drug Establishment (EDE), including implementation of the recent Decree-Law effective January 2, 2025
Compliance with international Regulations & Guidelines:
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Need to build a facility from scratch?
Why Most Facility Builds Fail?
(Even With Capital in Place)
- No single partner owns the full lifecycle:
funding → build → qualify → license → manufacturing - Design and construction vendors move fast—without a regulator-facing GMP lead in the room
- Internal QA/QC teams are looped in too late to prevent rework or compliance gaps
- Licensing timelines are vague—and often slip by 6–12 months
- Millions are spent building... then stall due to compliance issues
This is avoidable
2040 Consulting solves this by owning the entire lifecycle.
Facing pressure or QMS system issues?
Retained GMP Services & Regulatory Remediation—On Standby
Audit → Findings → QMS → Recovery → Release
Embedded GMP services for inspections, remediation, and interim QP/RP support—mobilized in 24–48h.
Even mature sites with strong people and systems can fall behind when:
- Audit findings pile up, and CAPAs drag on for months
- Internal QA/QC teams are understaffed or lack capacity
- Regulatory findings or licensing delays create commercial risk
- No clear lead takes ownership of QMS recovery across functions
- Short-term consultants come and go—but nothing gets closed
Every week lost delays batch release, triggers investor concern, and increases regulator scrutiny.
2040 Consulting embeds leadership fast, clears the backlog, and restores regulatory confidence—without creating new layers of complexity.
Why 2040 Consulting?
Led by PJ Murphy —
Senior GMP Leadership You Can Trust
“I help life sciences companies and their investors navigate GMP execution—from build to remediation.”
With over 20 years of GMP delivery across the US, EU, and India, PJ Murphy has led:
- Facility builds, QMS overhauls, and regulatory remediation for global manufacturers & distributors
- Projects under FDA, EMA, HPRA, MOHAP, and EDE
- Batch release and QA oversight for manufacturing restarts and licensed distribution networks
- Capital project leadership at companies including Amgen, Takeda, and Alexion
- Deployment of 30-person taskforces across 3 continents in 14 days
- Regulatory inspections with zero critical or major observations
Personally Accountable
You work directly with PJ on every engagement.
Regulator - Facing
We speak directly to FDA, EMA, MOHAP, and more.
Globally Deployable
On-site in 24–48h across MENA, EU, US, and India.
Based in Dubai, deployable globally within 24–48 hours
Why 2040 Consulting?
Led by PJ Murphy —
Senior GMP Leadership You Can Trust
Senior GMP Leadership You Can Trust
B.Sc. Biotechnology
M.Sc. Biotechnology
M.Sc. Pharmaceutical Technology
M.Sc. Quality Systems / Qualified Person (QP) – (QP eligible Sept 2025)
PMP – Project Management Professional
With over 20 years of GMP delivery across the US, EU, and India, PJ Murphy has led:
- Facility builds, QMS overhauls, and regulatory remediation for global manufacturers & distributors
- Projects under FDA, EMA, HPRA, MOHAP, and EDE
- Batch release and QA oversight for manufacturing restarts and licensed distribution networks
- Capital project leadership at companies including Amgen, Takeda, and Alexion
- Deployment of 30-person taskforces across 3 continents in 14 days
- Regulatory inspections with zero critical or major observations
Personally Accountable
You work directly with PJ on every engagement.
Regulator - Facing
We speak directly to FDA, EMA, MOHAP, and more.
Globally Deployable
On-site in 24–48h across MENA, EU, US, and India.
Based in Dubai, deployable globally within 24–48 hours
Strategic Advantage:
From Dubai, PJ operates within an 8-hour flight of 80% of the world’s life sciences companies—ready to embed fast when timelines, regulators, or investors demand results.
Want senior GMP leadership on your project?
Let’s talk through your build, licensing, or remediation needs.
Ready to Build or Recover with Speed and Compliance?
Whether you're launching a new GMP facility or stabilizing after regulatory pressure, we lead from funding through first batch—or step in fast when compliance is at risk.
Interested in more solutions?
Interested in more solutions?