ISO 9001
QMS
PIC/S
GDP
Swissmedic/ EU GMP
TG & PureOne Program
Our standards
Axcura operates with quality and compliance as the foundation of every decision, ensuring that all materials, services, and supply-chain activities meet the expectations of pharmaceutical and biopharmaceutical customers worldwide.
Our approach is designed to support innovators, generic manufacturers, CMOs, and CDMOs operating in regulated environments where quality, traceability, and regulatory robustness are critical.
Our Quality & Compliance framework is built on ISO 9001 and PIC/S GDP-aligned systems, supported by rigorous supplier and material qualification, structured change control, and transparent documentation practices. Through defined qualification programs, regulatory oversight, and secure handling of regulated materials (including controlled substances), Axcura ensures compliance, supply reliability, and audit readiness from early development through long-term commercial supply.
Our Quality Framework
Axcura maintains a robust, risk-based Quality Management System focused on transparency, consistency, and control across the full supply chain.
Core elements of our quality framework include:
Change Control, Deviation and CAPA management
Defined vendor and material qualification processes
Documented batch-level traceability and transparency
Risk-based material criticality classification
Secure handling of regulated and controlled materials
Qualified and audited manufacturers and suppliers
This framework ensures consistent quality performance from early development through long-term commercial supply.
Vendor & Material Qualification
All manufacturers, suppliers, and service providers are subject to formal qualification and approval prior to onboarding.
Qualification is performed based on material criticality, regulatory exposure, intended use, and supply risk.
Qualification activities may include:
Quality questionnaires and documentation review
Risk assessments and criticality classification
Certification and regulatory status verification
Ongoing performance monitoring and requalification
Audit coordination and follow-up where required
Qualified and audited manufacturers and suppliers
This ensures that only qualified and compliant partners are integrated into Axcura’s supply network, minimizing qualification burden for customers.
Regulatory Compliance & Documentation
Axcura supports regulatory readiness through complete, accurate, and traceable documentation aligned with customer and authority expectations.
Depending on product category and use, this may include:
Certificates of Analysis (CoA)
GMP / GDP compliance documentation
Change notifications and impact assessments
Regulatory statements and declarations
Controlled substance documentation where applicable
Qualified and audited manufacturers and suppliers
Our documentation practices are designed to support customer audits, inspections, and regulatory submissions without unnecessary complexity.
Good Distribution Practice (GDP)
Axcura operates in accordance with PIC/S GDP principles, ensuring that materials are stored, handled, and transported in a manner that preserves quality, integrity, and traceability.
Key GDP elements include:
Defined storage and handling conditions
Qualified logistics and transport partners
Temperature and condition monitoring where required
Secure supply-chain processes and documentation
Deviation handling and corrective actions
Qualified and audited manufacturers and suppliers
This ensures product integrity throughout the entire distribution lifecycle.
TG & PureOne Quality Programs
In addition to standard quality systems, Axcura applies portfolio-specific quality programs to address higher-risk applications and critical materials.
Trusted Goods (TG):
A quality label applied to materials with defined qualification depth, traceability, and supplier oversight, suitable for regulated pharmaceutical applications.
PureOne:
A dedicated quality program for high-purity and low-endotoxin (LBLE) materials used in biopharmaceutical and advanced therapy manufacturing, addressing enhanced requirements for purity, consistency, and process robustness.
Qualified and audited manufacturers and suppliers
These programs provide clear quality differentiation aligned with application risk and regulatory expectations.
Audit Readiness & Transparency
Axcura operates with a strong focus on audit readiness and transparency. Our quality organization supports customer audits, inspections, and technical discussions in a structured and cooperative manner.
We act as a quality-focused partner, ensuring alignment between manufacturers, logistics providers, and customers while minimizing unnecessary audit duplication and administrative burden.
Qualified and audited manufacturers and suppliers
Commitment to Continuous Improvement
Quality at Axcura is not static. Our systems and processes are continuously reviewed and improved.
Improvements are based on:
Regulatory developments
Customer feedback
Internal performance metrics
Supplier performance trends
Qualified and audited manufacturers and suppliers
This ensures that our quality framework evolves in line with industry expectations and regulatory standards.
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