Our Services

Validation transformation, delivered from diagnosis to digital control.

Founder-led consulting, turnkey validation execution and PHARPRO DVS for regulated pharmaceutical teams across MENA.

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Packaged engagements

Choose a clear starting point

You receive a defined scope, timeframe and deliverable—not an open-ended consulting retainer.

2–3 weeks

Validation Compliance Diagnostic

Risk-ranked review and remediation roadmap for systems, documents and validation governance.

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2–4 weeks

Inspection Readiness Sprint

Critical evidence review, mock inspection findings and an owned action plan.

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Project-based

Turnkey Validation Delivery

Coordinated VMP, URS, risk, CQV, CSV, execution, deviation closure and handover.

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Scoped study

CQV & Thermal Mapping

Risk-based protocols, controlled field execution, data assessment and final reporting.

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Computerized System Validation (CSV)

End-to-end CSV lifecycle support - URS, risk classification, IQ/OQ/PQ protocols, audit-trail review, and Validation Summary Reports. Aligned with FDA 21 CFR Part 11, EU GMP Annex 11, and ISPE GAMP 5.

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Quality Assurance & Gap Assessment

QA programme reviews, gap assessments against regulatory expectations, SOP development, CAPA management, data integrity audits, and inspection readiness support for regulated pharma operations.

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CQV & Thermal Mapping

Commissioning, Qualification, and Validation for pharmaceutical equipment and utilities. Thermal mapping studies for cold chain storage and temperature-controlled environments - aligned with EU GMP Annex 15.

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GMP Training

Instructor-led pharmaceutical training programmes - Cleaning Validation, CSV, Compressed Air Testing, and EU GMP Annex 1. Delivered online and on-site for pharma teams across Jordan and MENA.

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Pharma Digital Support & DVS

Compliance-first digital transformation - Pharma 4.0 strategy, AI-assisted validation, software implementation, and PHARPRO DVS controls designed to support Part 11 assessments.

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21 CFR Part 11 Consulting

Gap assessments and remediation for electronic records, audit trails, electronic signatures, access controls and computerized system validation across the Middle East.

Part 11 consulting details →