Compliant facilities, qualified systems, validated processes — from concept to handover.
Pharmaceutical Engineering
Compliance is engineered into a facility long before it is inspected. PharmExpert brings end-to-end engineering expertise to pharmaceutical projects — from greenfield and brownfield facility design through detailed engineering, commissioning and qualification, validation, procurement and construction supervision.
We apply a science- and risk-based approach aligned to ISPE baseline guidance, ASTM E2500, EU GMP Annex 1 and Annex 15, and ICH — delivering facilities and systems that are compliant by design, built to schedule and qualified for use.
Standards & Frameworks
- EU GMP Annex 1 & 15
- ISPE Baseline Guides
- WHO GMP facilities
- 21 CFR 211 Subpart C
- EU GMP Annex 15
- ASTM E2500
- GEP (Good Engineering Practice)
- EU GMP Annex 1
- ISO 14644
- ISPE C&Q guidance
- FDA Process Validation Guidance
- ICH Q8–Q12
Talk to a pharmaceutical engineering specialist
Tell us about your challenge and we'll propose a scoped, independent engagement — with a transparent quote.