Our Services
Comprehensive pharmaceutical consulting services tailored to your needs
Products and Site registration and approval
Preparation and management of complete regulatory dossiers for pharmaceutical products and manufacturing sites, ensuring compliance with Iraqi Ministry of Health (MOH) requirements and facilitating efficient registration, approval, and market authorization.
Marketing research and feasibility study for pharmaceutical industry.
Comprehensive market analysis, competitor evaluation, investment assessment, demand forecasting, and technical feasibility studies to support informed pharmaceutical business decisions and successful project implementation.
Risk assessment
Comprehensive market analysis, competitor evaluation, investment assessment, demand forecasting, and technical feasibility studies to support informed pharmaceutical business decisions and successful project implementation.
GAP analysis and Auditing
Detailed assessment of existing operations against GMP and Iraqi MOH requirements to identify compliance gaps, recommend corrective actions, and prepare facilities for successful regulatory inspections.
QMS - Quality management system establishment
Development and implementation of a complete pharmaceutical Quality Management System including SOPs, documentation, quality processes, and continuous improvement aligned with GMP requirements.
HVAC Qualification
Qualification of pharmaceutical HVAC systems through Design, Installation, Operational, and Performance Qualification (DQ/IQ/OQ/PQ) to ensure controlled manufacturing environments.
Production machines Qualification
Complete qualification of manufacturing equipment to verify installation, operation, and performance while ensuring reliable, compliant, and reproducible pharmaceutical production.
Water system Qualification
Qualification and validation of purified water and water-for-injection systems to demonstrate consistent performance and compliance with pharmaceutical quality standards.
Thermal Mapping studies
Temperature and humidity mapping of storage areas, warehouses, incubators, and controlled environments to verify uniform environmental conditions and support regulatory compliance.
Quality control Equipments qualification
Qualification of laboratory instruments to confirm installation, accuracy, precision, and performance, ensuring reliable analytical results throughout the equipment lifecycle.
Process validation
Scientific verification that manufacturing processes consistently produce products meeting predetermined quality specifications and regulatory requirements.
Cleaning validation
Validation of cleaning procedures to demonstrate effective removal of product residues, contaminants, and cleaning agents, preventing cross-contamination between manufacturing campaigns.
Pharmacovigilance building system and Files preparation
Development of pharmacovigilance systems, documentation, SOPs, and regulatory files in accordance with Iraqi MOH requirements and international pharmacovigilance guidelines.
Products and Site registration and approval
Preparation and management of complete regulatory dossiers for pharmaceutical products and manufacturing sites, ensuring compliance with Iraqi Ministry of Health (MOH) requirements and facilitating efficient registration, approval, and market authorization.
Marketing research and feasibility study for pharmaceutical industry.
Comprehensive market analysis, competitor evaluation, investment assessment, demand forecasting, and technical feasibility studies to support informed pharmaceutical business decisions and successful project implementation.
Risk assessment
Comprehensive market analysis, competitor evaluation, investment assessment, demand forecasting, and technical feasibility studies to support informed pharmaceutical business decisions and successful project implementation.
GAP analysis and Auditing
Detailed assessment of existing operations against GMP and Iraqi MOH requirements to identify compliance gaps, recommend corrective actions, and prepare facilities for successful regulatory inspections.
QMS - Quality management system establishment
Development and implementation of a complete pharmaceutical Quality Management System including SOPs, documentation, quality processes, and continuous improvement aligned with GMP requirements.
HVAC Qualification
Qualification of pharmaceutical HVAC systems through Design, Installation, Operational, and Performance Qualification (DQ/IQ/OQ/PQ) to ensure controlled manufacturing environments.
Production machines Qualification
Complete qualification of manufacturing equipment to verify installation, operation, and performance while ensuring reliable, compliant, and reproducible pharmaceutical production.
Water system Qualification
Qualification and validation of purified water and water-for-injection systems to demonstrate consistent performance and compliance with pharmaceutical quality standards.
Thermal Mapping studies
Temperature and humidity mapping of storage areas, warehouses, incubators, and controlled environments to verify uniform environmental conditions and support regulatory compliance.
Quality control Equipments qualification
Qualification of laboratory instruments to confirm installation, accuracy, precision, and performance, ensuring reliable analytical results throughout the equipment lifecycle.
Process validation
Scientific verification that manufacturing processes consistently produce products meeting predetermined quality specifications and regulatory requirements.
Cleaning validation
Validation of cleaning procedures to demonstrate effective removal of product residues, contaminants, and cleaning agents, preventing cross-contamination between manufacturing campaigns.
Pharmacovigilance building system and Files preparation
Development of pharmacovigilance systems, documentation, SOPs, and regulatory files in accordance with Iraqi MOH requirements and international pharmacovigilance guidelines.