Explore Our Case Studies
Proven GMP Results
Delivered Under Pressure, On Time, and Globally Compliant
Impact in different regions:
Explore Our Case Studies
Proven GMP Results
Delivered Under Pressure, On Time, and Globally Compliant
Impact in different regions:
What We Do is Clear.
Here’s What That Looks Like in the Real World.
From facility expansions and lab relocations to regulatory recovery and FDA close-outs, 2040 Consulting delivers GMP-critical results under tight timelines and global scrutiny.
€120M Sterile BDS Expansion
→ Impact: Europe
- Project Type: Full facility acceleration | EMA / HPRA / FDA
- Duration: 18 months
A new market contract required GMP-ready bulk-drug-substance manufacturing within 18 months. Missing the timeline would forfeit first-mover advantage and multi-year revenue.
- Results:
- Delivered €120M facility on schedule and inspection-ready
- All CQV protocols executed with zero critical observations
- First GMP batches released on time for market launch
- Our Role:
Embedded as senior project lead, we aligned engineering, CQV, and procurement, compressed the CQV timeline, and ensured zero regulatory slippage.
$250M Combination-Product Line Expansion
→ Impact: North America
- Project Type: Device + packaging + serialization build | FDA / Health Canada
- Duration: 18 months
To capitalize on a new auto-injector opportunity, the client had to add a full device-packaging line on a sterile fill-finish campus—without halting live production.
- Results:
- Commercial lots released to US and Canada
- FDA & Health Canada inspections passed with zero observations
- First GMP batches released on time for market launch
- Our Role:
Acted as GMP integration lead across capital, validation, and QA, delivering an 18-month expansion with zero production downtimee.
QC Lab Relocation & Requalification
→ Impact: EU
- Project Type: Lab move | HPRA / FDA
- Duration: 12 months
A solid-oral-dose site needed to move all QC functions—including stability and water testing—to a new building, without interrupting production or batch release.
- Results:
- All equipment calibrated and qualified on schedule
- No observations during HPRA or FDA inspections
- Stability program resumed with zero data integrity concerns
- Our Role:
Led the relocation end-to-end: capital approval, vendor coordination, change-controls, and full IOQ/PQ—all without a single hour of production downtime.
Global QC Method-Transfer
→ Impact: US, PR, EU
- Project Type: Method transfer for 13 biologics | HPRA / FDA
- Duration: 12 months
To hit regulatory filing deadlines, 13 biologic products (20 methods each) had to be transferred from US and PR sites to 4 EU labs—amid resource constraints and stalled logistics.
- Results:
- 13 products / 20 methods each transferred to 4 labs
- Zero repeat investigations
- Awarded Corporate Project-Delivery Award for quality and timeline
- Our Role:
Acted as Method-Transfer Site Lead, aligning global teams, unblocking reagent supply, and executing the company’s fastest transfer ever.
Compliance Crisis Turnaround
→ Impact: EU
- Project Type: Critical findings recovery | HPRA
- Duration: 12 weeks
HPRA issued multiple Critical and Major findings. Batch release froze, CAPAs ballooned, and reputation eroded by the week.
- Results:
- 100% deviation backlog cleared in 90 days
- Full QMS rebuilt on schedule
- No repeat findings on reinspection
- Our Role:
Led a single, senior-led taskforce to triage CAPAs, rebuild the QMS, and satisfy regulators before escalating penalties took hold.
FDA 483 / OAI Recovery
→ Impact: India
- Project Type: OAI remediation | FDA
- Duration: 24 months
After receiving an FDA 483 with OAI status, the site faced halted batch release, regulatory heat, and investor pressure. Internal teams could not close fast enough.
- Results:
- US batch release reinstated while still under OAI
- 60% deviation backlog cut in 90 days
- Site moved toward compliance; remediation plan accepted by FDA
- Our Role:
Embedded a senior taskforce to lead risk-ranked CAPA closure, rebuild SOPs, restart manufacturing, and steer the site toward final FDA close-out.
Ready to Build a Track Record Like This?
Let’s discuss how we can deliver for your site, your investors, or your regulators—with the same precision and speed.