Engineering, regulatory, validation and project management services built specifically for pharmaceutical manufacturing.
Material and personnel flow mapped to GMP zoning.
Air handling systems sized for class-controlled environments.
Purified water and WFI generation, storage and distribution loops.
Panel systems, airflow and finishes matched to your classification.
Steam, compressed air, chilled water and gas systems, sized and routed.
Facility and documentation compliance to WHO good manufacturing practice.
Design and documentation aligned to EU GMP annexes.
Facility readiness support for USFDA inspection expectations.
Revised Schedule M and ISO documentation prepared and maintained.
Design qualification against user requirement specifications.
Installation qualification verifying build against approved design.
Operational qualification confirming systems run to specification.
Performance qualification and computer system validation.
Equipment and contractor sourcing matched to project scale.
On-site oversight of civil, mechanical and utility works.
Systematic start-up and handover of qualified systems.
Cost tracking and schedule management from kickoff to closeout.
Greenfield tablet and capsule facility with integrated warehouse and QC labs.
Cleanroom and HVAC upgrade for EU-GMP compliance on an existing injectable line.
DQ / IQ / OQ / PQ of purified water and WFI generation and distribution loops.
Full facility design and documentation for a new nutraceutical manufacturing line.
Process and utility retrofit that raised throughput on an existing topical line.
Turnkey execution from layout approval through commissioning and handover.
What manufacturers commonly miss when preparing for a WHO-GMP facility assessment.
A breakdown of the revised Schedule M requirements and how to plan for them.
The fundamentals of designing a cleanroom that holds its classification in operation.
Lessons from the field on keeping DQ/IQ/OQ/PQ documentation audit-ready.
Why utility planning in the concept phase saves rework during commissioning.
Key decisions when specifying generation, storage and distribution loops.
Share your project brief and we'll recommend the right scope of work.
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