All Case Studies
PharmaceuticalsEPCMiddle East2023
Oral Solid Dosage Pharma Facility
EPC delivery of a USFDA-grade oral solid dosage facility — including HVAC, cleanrooms, granulation, compression and blister packaging suites.
Client · Confidential Generics Manufacturer
8,400 m²
Cleanroom Area
0
USFDA Observations
22
Validated SKUs
<2%
Schedule Variance
The Challenge
Greenfield site with no local engineering depth, regulatory exposure to USFDA, EU-GMP and PIC/S, and a non-negotiable validation milestone tied to product launch.
Our Solution
End-to-end EPC including process design, cleanroom build-out, equipment procurement from validated OEMs, qualification protocols (DQ/IQ/OQ/PQ) and CSV support.
Outcome
Facility cleared USFDA pre-approval inspection on first attempt with zero Form 483 observations. Validated 22 product lines within 9 months of handover.
Project Gallery
On-site execution
Up Next