Gold-Standard Excellence: Where Compliance Meets
Competitive Advantage
At Aryeh, quality is not just a requirement; it’s our
foundation. Every product, process, and partnership is
built to meet or exceed the most stringent global
standards, ensuring safety, reliability, and trust at
every step.
Measurable Excellence In Action
Our performance metrics reflect a culture of precision,
consistency, and regulatory discipline, delivering confidence to
every partner and patient we serve.
>98%
First-Pass Quality Rate
<0.1%
Customer Complaint Rate
100%
Regulatory Inspection Success
>99%
On-Time Delivery
QUALITY & COMPLIANCE
No-compromise Quality: Where Standards Drive Trust
Aryeh’s quality framework is built on rigorous regulatory
compliance, global certifications, and integrated systems that
ensure every product meets the highest benchmarks in safety,
consistency, and performance.
FDA & GMP Compliance
Strict adherence to 21 CFR Part 210 & 211 with
continuous FDA inspection readiness and electronic records
compliance.
Continuous FDA inspection readiness
International Standards
Full alignment with ISO 13485, ICH pharmaceutical
guidelines, WHO-GMP, and BRC global safety standards.
Certified through 2025–2026
Integrated Quality Systems
Real-time monitoring, statistical process control, and
risk-based quality management for consistent excellence.
Ongoing continuous improvement programs
Global Certifications
cGMP, ISO 9001:2015, and WHO-GMP certifications across all
manufacturing facilities.
Zero critical findings in inspections
SUPPLY CHAIN RELIABILITY
End-to-End Quality Assurance
From supplier qualification to final distribution, Aryeh’s quality framework safeguards every step, ensuring each product meets the highest standards of safety, efficacy, and reliability.
Supplier Qualification & Management
Rigorous onboarding programs with risk-based monitoring and evaluation
Manufacturing Excellence
State-of-the-art facilities with advanced process control and continuous monitoring
Distribution Integrity
Temperature-controlled logistics with serialization and track-and-trace for supply chain security
Regulatory Leadership
Setting the Standard in Compliance Excellence
Our comprehensive certification portfolio reflects our commitment to the highest global benchmarks across manufacturing, quality, and compliance.
FDA RELATIONSHIP MANAGEMENT
Building strong, trust-based relationships with FDA regulators
Proactively communicating regulatory changes and industry updates
Collaborating to interpret and implement evolving guidance
Providing transparent compliance documentation at every stage
SUBMISSION EXCELLENCE
Expertise in ANDA preparation, submission, and approval processes
Designing and executing bioequivalence studies to FDA standards
Conducting post-market surveillance and safety reporting
Leveraging regulatory intelligence for strategic market planning
COMPLIANCE MONITORING
Ongoing monitoring of the regulatory landscape for timely action
Implementing robust internal audit and assessment programs
Maintaining corrective and preventive action (CAPA) systems
Training teams to ensure regulatory competency across functions
TRANSPARENCY & REPORTING
Real-time quality dashboards with performance metrics
Regular reporting of quality and compliance performance
Proactive communication of potential quality issues
Coordinated customer notification and corrective action measures
Work With Confidence
Partner With a Quality-First Manufacturer
From regulatory precision to global certifications, Aryeh delivers the reliability, compliance, and performance that partners and patients can trust.
