Quality Policy
At Alkan Chemical Europe, quality is the foundation of our operations and our most valuable promise to customers.
As a specialized distributor of pharmaceutical raw materials, we recognize that product quality, documentation integrity, and supply chain traceability are essential requirements in every transaction.
Our ISO 9001:2015-certified Quality Management System (QMS) ensures that each product we deliver meets international standards and is handled with the rigor expected by regulatory authorities and manufacturers across Europe, the Middle East, and North Africa.
At Alkan Chemical Europe, quality is the foundation of our operations and our most valuable promise to customers.
As a specialized distributor of pharmaceutical raw materials, we recognize that product quality, documentation integrity, and supply chain traceability are essential requirements in every transaction.
Our ISO 9001:2015-certified Quality Management System (QMS) ensures that each product we deliver meets international standards and is handled with the rigor expected by regulatory authorities and manufacturers across Europe, the Middle East, and North Africa.
Regulatory Compliance and Documentation Excellence
We supply materials that conform to major pharmacopoeial standards including Ph. Eur., USP, BP, and JP. All products are accompanied by:
- Certificate of Analysis (CoA)
- Technical and Safety Data Sheets (TDS/SDS)
- Drug Master Files (DMFs), CEPs, or ASMFs when available
- Regulatory declarations such as BSE/TSE-free, GMO status, allergen statements, residual solvents, and nitrosamine risk assessments
Each batch is fully traceable from source to delivery, and documentation is prepared to support product registration, audits, and regulatory inspections.
Supplier Qualification and Risk Control
We follow a structured, risk-based supplier qualification process that includes:
- Verification of GMP or ISO certifications and regulatory inspection history
- Review of technical documents, analytical procedures, and quality systems
- Ongoing performance monitoring through delivery consistency, non-conformance management, and communication responsiveness
We collaborate only with audited and approved manufacturers who meet international compliance requirements.
Quality Oversight in Logistics and Warehousing
We coordinate storage and shipment through a certified logistics partner located in Belgium, which complies with:
- Good Distribution Practice (GDP) and API handling protocols
- ISO 9001 and ISO 22000 for food, nutraceutical, and specialty-grade materials
- Segregated and controlled warehousing conditions with traceability and monitoring
This ensures that all goods are handled safely and meet the required storage specifications throughout the supply chain.
Client-Focused Quality Service
We support our customers by offering:
- Accurate and complete documentation tailored to regulatory submissions
- Fast responses to technical and quality-related inquiries
- Coordination with client QA departments to ensure readiness for inspections and batch approvals
Our team is trained to understand and align with customer-specific compliance needs.
Continuous Improvement and Regulatory Awareness
Our internal processes are routinely evaluated and upgraded through:
- Scheduled reviews of the QMS and internal audits
- Regular training on current regulatory guidelines
- Implementation of corrective and preventive actions (CAPA)
- Feedback mechanisms from both customers and suppliers to improve service levels
We are committed to adapting our systems and knowledge base to reflect evolving industry standards.
Regulatory Compliance and Documentation Excellence
We supply materials that conform to major pharmacopoeial standards including Ph. Eur., USP, BP, and JP. All products are accompanied by:
- Certificate of Analysis (CoA)
- Technical and Safety Data Sheets (TDS/SDS)
- Drug Master Files (DMFs), CEPs, or ASMFs when available
- Regulatory declarations such as BSE/TSE-free, GMO status, allergen statements, residual solvents, and nitrosamine risk assessments
Each batch is fully traceable from source to delivery, and documentation is prepared to support product registration, audits, and regulatory inspections.
Supplier Qualification and Risk Control
We follow a structured, risk-based supplier qualification process that includes:
- Verification of GMP or ISO certifications and regulatory inspection history
- Review of technical documents, analytical procedures, and quality systems
- Ongoing performance monitoring through delivery consistency, non-conformance management, and communication responsiveness
We collaborate only with audited and approved manufacturers who meet international compliance requirements.
Quality Oversight in Logistics and Warehousing
We coordinate storage and shipment through a certified logistics partner located in Belgium, which complies with:
- Good Distribution Practice (GDP) and API handling protocols
- ISO 9001 and ISO 22000 for food, nutraceutical, and specialty-grade materials
- Segregated and controlled warehousing conditions with traceability and monitoring
This ensures that all goods are handled safely and meet the required storage specifications throughout the supply chain.
Client-Focused Quality Service
We support our customers by offering:
- Accurate and complete documentation tailored to regulatory submissions
- Fast responses to technical and quality-related inquiries
- Coordination with client QA departments to ensure readiness for inspections and batch approvals
Our team is trained to understand and align with customer-specific compliance needs.
Continuous Improvement and Regulatory Awareness
Our internal processes are routinely evaluated and upgraded through:
- Scheduled reviews of the QMS and internal audits
- Regular training on current regulatory guidelines
- Implementation of corrective and preventive actions (CAPA)
- Feedback mechanisms from both customers and suppliers to improve service levels
We are committed to adapting our systems and knowledge base to reflect evolving industry standards.