WELCOME TO QEEMA EGYPT

Q: What types of consultation services do you offer?

We provide expert consultation in Quality Management Systems (QMS), Health, Safety & Environment (HSE), Water Treatment Systems, Electromechanical Maintenance and Design, and Fire Alarm and Fire Fighting System Services.

Q: Who can benefit from your services?

Our services are suitable for industries such as Pharmaceuticals and Biotechnology, Food and Beverage, Manufacturing, Healthcare, and Utilities.

Premier GMP Consulting, Pharmaceutical Validation, and Qualification Experts

Why QEEMA?

QEEMA Egypt is your specialized partner for pharmaceutical consulting, validation, and qualification. Collaborating with leading pharmaceutical manufacturers, we provide end-to-end technical compliance solutions that satisfy both EDA regulations and international guidelines like EU GMP and US FDA.

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Quality Management System (QMS)

GMP & ISO compliance, SOP development, internal audit preparation, CAPA management, and regulatory compliance strategies.

Validation & Qualification

Equipment qualification (IQ/OQ/PQ), HVAC validation, purified water/WFI qualification, cleanroom monitoring, and thermal mapping.

Startup Projects & Engineering

Conceptual layout design for pharmaceutical facilities, equipment URS preparation, DQ validation, and turnkey project support.

15+

Years Experience

About Qeema Egypt

Delivering GMP Excellence Across Egypt & MENA

QEEMA is a leading pharmaceutical consultancy firm specializing in technical validation, equipment qualification, cleanroom air validation, and QMS compliance. We support pharmaceutical, biotech, and medical device manufacturers with GMP turnkey solutions, ensuring alignment with EDA, WHO, and EU GMP requirements.

GMP Consultation

Quality Risk Management, Audits, SOP writing, and CAPA implementation.
Validation & Qualification

HVAC, pure water (PW/WFI), equipment IQ/OQ/PQ, and computer system validation.
Pharma Engineering & Startup

Facility conceptual design, workflow layouts, and equipment DQ support.

PROVEN PHARMACEUTICAL EXPERTISE

Trusted Experience. Measurable Achievements.

Supporting pharmaceutical and regulated industries with specialized GMP consulting, validation, qualification and technical compliance solutions.

15+

Years of Experience

Delivering GMP compliance excellence across MENA

25+

Pharma Experts

Engineers, QA leads & regulatory scientists

80+

Pharma Partners

Leading manufacturers & biotech facilities

120+

Projects Completed

Turnkey validation, CSV & startup projects

100%

GMP Compliance

Strict EDA, WHO, FDA & EU GMP alignment

Our Services

Specialized GMP consultation and technical validation services tailored for the pharmaceutical and biotech industries in Egypt and the MENA region.

Regulatory Affairs Services

Regulatory Strategy & Product Registration
CTD / eCTD Preparation & Publishing
Dossier Gap Analysis & Labeling Compliance
EDA, FDA, EMA, SFDA & Global Authority Liaisons

CTD Service (Dossier Prep)

Preparation & compilation of CTD/eCTD dossiers
Review & formatting of Modules 1–5 (EDA/ICH)
Module 3 quality & technical documentation
Support in responding to deficiency letters

Software Validation (CSV)

Computer System Validation (CSV) per GAMP5
IQ/OQ/PQ protocols for software & lab systems
Risk assessment & URS development
21 CFR Part 11 & data integrity compliance

Software Upgrade Service

System upgrades via formal change control
Partial or full re-validation post-upgrade
Update of related documentation & SOPs
Compatibility testing with connected systems

Quality Management System (QMS)

ISO 9001 & GMP Implementation
Internal Audits & Gap Analysis
CAPA Planning & SOP Development
Staff Quality Training

Health, Safety & Environment (HSE)

OSHA & ISO 14001/45001 Audits
Risk Assessments (HIRA, JSA)
Safety Programs & PPE Training
Waste Management Compliance

Electromechanical Services

HVAC & Utilities Maintenance
Energy Efficiency Audits
Automation & Control Systems
Lifecycle & Spare Parts Planning

Validation and Qualification

HVAC & Water System Qualification
Equipment Qualification (IQ, OQ, PQ)
Computer System Validation (CSV)
Thermal Mapping (WHO TRS 961)

Startup Projects

Conceptual Design & Facility Layouts
Equipment URS & Design Validation (DQ)
Full Turnkey Facility Setup Support
Regulatory Licensing & Launch Audit

Fire Systems Services

Alarm & Fighting System Design
Installation & Maintenance
Local Codes & Civil Defense Approvals
GMP Facility Integration

Sampling & Testing (PW, WFI & EM)

Purified Water (PW) & WFI Testing
Cleanroom Environmental Monitoring (EM)
TOC, Bioburden & Endotoxin LAL
Pure Steam & Gas Microbial Sampling

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Our Specialized Departments

Expert consulting, validation, and regulatory divisions dedicated to pharmaceutical and industrial compliance.

Regulatory Affairs & CTD Department

Strategic regulatory roadmaps, CTD/eCTD dossier preparation, product registration, and authority communications (EDA, FDA, EMA, SFDA).

Regulatory Strategy & Planning
CTD / eCTD Modules 1-5
Dossier Gap Analysis
Labeling & SmPC Compliance
Deficiency Response Support
Variations & License Renewals

Explore Regulatory Services

Quality Management System (QMS) Department

Designing audit-ready Quality Systems for pharmaceutical, biotech, and medical device manufacturers per ISO 9001, ISO 13485, and EU GMP.

Document Control & SMF
Quality Compliance Audits
Staff Quality & GDP Training
Deviation & CAPA Tracking
Formal Change Control
Quality Risk Management

Explore QMS Department

Validation & Qualification Department

Scientific qualification of equipment, cleanroom HVAC smoke studies, pure water loops, thermal mapping, and process validation.

Equipment Qualification (IQ/OQ/PQ)
Cleanroom HVAC & Smoke Studies
Pure Water (PW/WFI) Loops
WHO TRS 961 Thermal Mapping
Cleaning & Process Validation
HEPA Filter DOP Leak Testing

Explore Validation Department

Pharma Sampling & Testing (PW, WFI & EM)

GMP-compliant microbiological & chemical sampling and testing for Purified Water (PW), Water for Injection (WFI), Pure Steam, and Cleanroom Environmental Monitoring (EM).

Purified Water (PW) & WFI Testing
TOC & Conductivity Analysis
Bioburden & Endotoxin LAL Testing
Cleanroom EM Active & Settle Plates
Pure Steam & Gas Sampling
Alert/Action Limit Trend Analysis

Explore Sampling Services

Software & Computer System Validation (CSV)

Comprehensive CSV services per GAMP 5, 21 CFR Part 11 electronic signatures, and ALCOA+ data integrity rules for lab and plant systems.

GAMP 5 Validation Life-cycle
21 CFR Part 11 Compliance
LIMS & CDS System Audit
SCADA & PLC Software IQ/OQ
Audit Trail & Security Audit
Software Upgrade Re-validation

Explore Software & CSV

Pharma Startup & Engineering Consulting

Partnering with investors and factories from conceptual cleanroom layouts to machinery URS, Design Qualification (DQ), and EDA licensing.

Conceptual Layout & Flow Design
Equipment URS Specifications
Design Qualification (DQ)
Construction & Finishes Audit
Validation Master Plan (VMP)
EDA Regulatory Licensing

Explore Startup Projects

Electromechanical & Utilities Engineering

Specialized engineering for cleanroom HVAC units, purified water (PW/WFI) loops, BMS automation, and preventive maintenance planning.

Cleanroom HVAC & Duct Sizing
Pure Water (PW/WFI) Loops
BMS & EMS Sensor Calibration
Orbital Welding Quality Check
Preventive Maintenance (PM)
Utility Energy Efficiency Audits

Explore Electromechanicals

Health, Safety & Environment (HSE)

Implementing workplace health and safety protocols and environmental management systems aligned with OSHA, ISO 14001, ISO 45001, and EEAA.

Occupational Health & Safety
ISO 14001 Environmental System
ISO 45001 Safety Management
HIRA & JSA Risk Assessments
EEAA Waste Compliance Logs
Emergency Evacuation Drills

Explore HSE Department

Fire Safety & Suppression Systems

Engineering NFPA-compliant fire alarm and clean agent suppression systems (FM-200, Novec) tailored for cleanrooms and industrial facilities.

Cleanroom FM-200 Gas Systems
NFPA 72 Addressable Fire Alarms
NFPA 13 Sprinkler Networks
HVAC Damper Shut-off Interlocks
Fire Pump Testing & Commissioning
Civil Defense Licensing Support

Explore Fire Systems

Leadership Team

Meet our leading pharmaceutical engineering and GMP compliance experts driving validation excellence across the MENA region.

Dr. Mahmoud Ayad

Technical Director & GMP Consultant

Over 14 years of professional expertise in sterile facility validation, autoclave and dry heat sterilization, HVAC system validation, aseptic filling line audits, and EU GMP / US FDA regulatory compliance.

Dr. Amany Tanany

Chief Executive Officer (CEO) & QMS Expert

15+ years of specialized experience in Quality Management Systems (QMS) implementation, sterile manufacturing operations, documentation control, and preparing facilities for EDA licensing and audits.

Frequently Asked Questions

Quick answers to frequently asked questions clients may have about our consulting services.

What types of consultation services do you offer?

We provide expert consultation in the following areas: Quality Management Systems (QMS) , Health , Safety & Environment (HSE) , Water Treatment Systems , Electromechanical Maintenance and Design , Fire Alarm and Fire Fighting System Services

Who can benefit from your services?

Our services are suitable for industries such as: Pharmaceuticals and Biotechnology , Food and Beverage , Manufacturing , Healthcare , Utilities and Facility Management

Do you help with regulatory compliance (e.g., ISO, GMP, OSHA)?

Yes. Our team ensures full compliance with local and international standards including: ISO 9001, 14001, 45001 , EU GMP & FDA guidelines , OSHA & local EHS regulations

Can you assist with system validation and equipment qualification?

Absolutely. We offer support in validation and qualification including: IQ/OQ/PQ Protocols , Validation Master Plans (VMPs) , Process Validation , Cleaning and Method Validation

Do you provide on-site or remote consultation?

We offer both options depending on client needs. On-site visits are ideal for audits, assessments, and equipment review, while remote sessions are effective for document reviews, training, and follow-up consultations.

What deliverables will I receive from the consultation?

Clients typically receive: Audit Reports or Gap Assessments , Compliance Roadmaps , SOPs and Documentation , Validation or Qualification Protocols , Training Records , Recommendations for Improvement

Can you help train our staff?

Yes, we offer customized training on: QMS fundamentals , EH&S best practices , Equipment operation and maintenance , Water treatment monitoring , Validation procedures

How do we get started with a consultation?

You can contact us via email or phone to schedule an initial consultation. We’ll conduct a needs assessment and provide a proposal tailored to your organization.