Life Sciences Capital Projects: Planning, Design and Commissioning & Qualification
GMP facilities leave no room for schedule slippage or undocumented decisions. We bring planning engineering, design coordination, commissioning and qualification support and digital traceability to pharmaceutical and biotechnology projects.
Our Perspective
In regulated manufacturing, the schedule and the evidence are the same thing. A project is only finished when every system is verified, documented and handed over ready for inspection.
Services
What We Deliver for Life Sciences Clients
Capital Project Planning
Integrated master schedules, sequencing, progress measurement and reporting for GMP facility programmes.
Commissioning & Qualification Support
Planning and tracking of commissioning, IQ, OQ and PQ activities against a risk-based C&Q strategy.
Digital C&Q & Traceability
Data structures, dashboards and AI-assisted workflows that show what is complete, what is missing and where action is needed.
Turnover & Handover Readiness
System-by-system turnover tracking so construction, commissioning and quality stay aligned.
Schedule Recovery
Critical path analysis and recovery planning when qualification milestones are at risk.
Utilities & Energy Performance
Process utilities and energy analysis for facilities with demanding HVAC, water and steam loads.
Risk-Based Commissioning & Qualification Lifecycle
Requirements on the left are verified on the right. Planning engineers track every stage, from specification to release.
Swipe sideways to see the full diagram.
Leadership Experience
Where Our Life Sciences Experience Comes From
Experience below describes our leadership’s individual careers, including roles before PQEA.
Pharmaceutical Manufacturing Programmes
Planning and controls management on capital projects for global pharmaceutical and biotechnology manufacturers.
Regulated Project Environments
Schedule, progress and turnover control in projects governed by GMP documentation and quality oversight.
C&Q Workflow Automation
Development of traceability logic and reporting tools that support qualification workflows and inspection readiness.
Specific project references are available under NDA.
Frequently Asked Questions
Do you provide validated or “FDA-approved” software?
No. We build tools that support GMP documentation and inspection readiness. Computer system validation and regulatory decisions remain with the facility owner and its quality organisation.
Can you work alongside our existing C&Q contractor?
Yes. We often work on the owner’s side, integrating C&Q progress into the master schedule and reporting.
Which frameworks do you work to?
We align with the client’s quality system and commonly used risk-based C&Q approaches, such as ASTM E2500 and ISPE guidance.
Delivering a GMP Facility?
Talk to us about planning, design coordination, C&Q tracking and turnover readiness.