From gap to green — get certified, inspection-ready, and stay there.
Regulatory Certification & Remediation Support
Knowing where you stand is only half the job; getting certified and closing the gap is the rest. PharmExpert helps you achieve and defend certification against WHO, PIC/S, EU GMP and US FDA expectations, prepare your people and systems for inspection, and remediate findings — from 483s and Warning Letters to Import Alerts — to verifiable closure.
We combine certification readiness, inspection and SME preparation, data-integrity assessment, structured CAPA development, and quality-culture transformation into one continuum, so findings become closed actions and sites pass inspections with confidence.
Standards & Frameworks
- WHO GMP / prequalification
- PIC/S
- EU GMP
- US FDA cGMP
- ISO 9001 / 13485
- US FDA inspection program / PAI
- EU GMP & EMA inspections
- WHO PQ inspections
- US FDA 483 / Warning Letter / Import Alert expectations
- ICH Q10
- ICH Q9
- ALCOA+
Talk to a regulatory certification & remediation support specialist
Tell us about your challenge and we'll propose a scoped, independent engagement — with a transparent quote.