International Standards
Comprehensive ISO standards implementation for pharmaceutical manufacturers. From quality management to environmental systems, we guide you through certification to open doors to international markets.
Discuss Your ISO NeedsOur Expertise
We provide end-to-end implementation and certification support across the ISO standards most relevant to pharmaceutical and life sciences manufacturing.
Quality Management Systems
The foundational quality management standard. Establishes a process-based approach to consistent product quality, customer satisfaction, and continuous improvement across your organization.
Environmental Management
Framework for environmental management systems. Helps pharmaceutical manufacturers minimize environmental impact, comply with regulations, and demonstrate corporate responsibility to stakeholders.
Medical Devices
Quality management standard specific to medical device design, development, and manufacturing. Essential for pharmaceutical companies that also produce combination products or medical devices.
Food Safety Management
Food safety management systems standard relevant to nutraceutical manufacturers and pharmaceutical companies producing dietary supplements, food-grade ingredients, or oral dosage products.
Pharmaceutical Packaging
Primary packaging materials standard for medicinal products. Combines ISO 9001 requirements with GMP principles specific to the design, manufacture, and supply of pharmaceutical packaging materials.
Our Methodology
A structured, proven approach to achieving ISO certification — from initial requirements analysis through successful certification audit.
We analyze the specific ISO standard requirements against your business context, regulatory obligations, and strategic objectives to define the scope and approach for your certification project.
We conduct a thorough assessment of your existing systems, processes, and documentation against the target standard, identifying gaps and prioritizing remediation activities by risk and effort.
We design the management system architecture tailored to your organization — including process maps, organizational roles, risk frameworks, and performance measurement structures.
We develop the complete documentation suite — quality manual, procedures, work instructions, forms, and records — ensuring they are practical, implementable, and meet the standard's requirements.
We guide the rollout of the management system across your organization — including staff training, process deployment, competency assessments, and management review establishment.
We conduct a comprehensive internal audit to verify conformity, identify any remaining nonconformities, and ensure corrective actions are effectively closed before the certification audit.
We provide end-to-end support during the Stage 1 and Stage 2 certification audits — from pre-audit preparation and document readiness through real-time guidance and post-audit corrective action response.
Strategic Value
For pharmaceutical manufacturers operating in an increasingly globalized market, ISO certifications are far more than compliance checkboxes. They serve as internationally recognized proof that your organization operates to the highest standards of quality, safety, and reliability — standards that customers, regulators, and business partners around the world understand and trust.
ISO certifications complement and strengthen FDA and GMP compliance. While cGMP sets the regulatory baseline for the US market, ISO standards provide a broader management system framework that enhances operational efficiency, reduces risk, and establishes structured approaches to continuous improvement. A manufacturer with both cGMP compliance and ISO certification demonstrates a mature, well-managed quality culture.
Critically, ISO certifications open doors to international markets beyond the United States. Many regulatory authorities in Europe, Asia, and the Middle East recognize ISO certifications as evidence of manufacturing capability. For MENA-region manufacturers seeking to diversify their export markets, ISO certification is often a prerequisite for market entry — making it not just a quality investment, but a strategic business decision.
Take the First Step
Contact our consulting team for a confidential assessment of your ISO certification needs. We'll recommend the right standards for your business, outline the implementation pathway, and provide a clear timeline to certification.
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