Seven connected service pillars designed for pharmaceutical compliance, audit readiness and reliable technical execution.
Seven integrated pillars of pharmaceutical quality and compliance.
Product registration, CTD/eCTD dossiers, regulatory strategy, variation & renewal, authority communication.
PV system setup, ADR management, PSUR/PBRER, signal detection, risk management plans.
GMP gap assessments, SOP preparation, internal & supplier audits, CAPA, inspection readiness.
Full DQ/IQ/OQ/PQ lifecycle for equipment, cleanrooms, HVAC, EMS, BMS per ISO 14644.
Process, cleaning, utility, autoclave, thermal mapping, cold-chain validation with full documentation.
Traceable on-site calibration for temperature, humidity, pressure, balances, data loggers.
Supporting companies entering or expanding in Iraq's pharmaceutical and healthcare market — regulatory pathway analysis, scientific office support, and governmental affairs.
Whether you need regulatory registration, GMP gap assessment, equipment qualification, or calibration — our team is ready.