Business Details
25 Years
experience
Emergency
services
Global Specialty Pharmaceutical Distribution Services
Founded in 2001, One World is a globally licensed international specialty pharmaceutical distributor committed to connecting medicine with critical healthcare needs. Our team combines 20+ years of expertise in navigating complex regulatory frameworks, logistics, and supply chain integrity to deliver FDA-approved medications worldwide. We specialize in addressing urgent medical requirements, including orphan drugs for rare diseases, managed access programs, and controlled substance distribution. Certified by the FDA, DEA, and Georgia Drugs and Narcotics Agency, our operations prioritize security, compliance, and environmental responsibility. With a multilingual team fluent in five languages, we provide tailored solutions for healthcare providers, clinical research organizations, and pharmaceutical manufacturers across 100+ countries.Our strategic Atlanta headquarters enables rapid global shipping, supported by advanced cold-chain packaging, real-time shipment monitoring, and partnerships with major transport providers like FedEx and DHL. We maintain rigorous quality management systems aligned with EU GDP guidelines and U.S. DSCSA standards, ensuring product safety and traceability. Our innovation lab fosters continuous process improvement, while community initiatives reflect our commitment to social and environmental stewardship. Recognized for consistent business growth, weve received five Globe Awards for international client expansion since 2015. By combining technical expertise with compassionate service, we bridge global treatment gaps for thousands of patients annually.
Services
Named Patient Supply
Orphan Drug Distribution
Controlled Substance Export
Managed Access Programs
Third-Party Logistics
Details
- Year established: 2001
Highlights and features
- 20+ years of international pharmaceutical logistics expertise
- Multilingual team fluent in five languages
- Real-time shipment monitoring with certified cold-chain technology
- Compliant with FDA, DEA, and EU GDP standards
- Award-winning global distribution network
Associations and certifications
- U.S. Food and Drug Administration (FDA)
- U.S. Drug Enforcement Agency (DEA)
- Georgia Drugs and Narcotics Agency (GDNA)
Services
Named Patient Supply
We facilitate access to critical medicines unavailable locally through ethical regulatory pathways. Our dedicated team expedites patient-specific shipments of discontinued, investigational, or scarce medications. With 24/7 supply chain monitoring and temperature-controlled logistics, we ensure timely, secure delivery of life-saving treatments across 100+ countries.
Orphan Drug Distribution
Our specialized program delivers treatments for rare diseases affecting fewer than 200,000 U.S. patients annually. We navigate complex import regulations while maintaining supply chain integrity through FDA-certified facilities. By partnering with rare disease advocacy groups, we identify unmet needs and streamline access to lifesaving therapies for underserved patient populations.
Controlled Substance Export
We handle international shipping of Schedule II-V controlled substances under strict DEA compliance. Our licensed staff coordinates with U.S. and foreign regulatory agencies to manage documentation, security protocols, and shipment tracking. Advanced storage facilities with biometric access controls ensure proper handling of high-risk pharmaceuticals throughout the distribution process.
Managed Access Programs
We connect patients with investigational therapies through compassionate use programs before market approval. Working directly with manufacturers, we manage regulatory submissions, patient eligibility assessments, and global distribution logistics for time-sensitive treatments targeting life-threatening conditions like rare cancers and genetic disorders.
Third-Party Logistics
Our logistics solutions combine 20+ years of pharmaceutical expertise with cutting-edge monitoring systems. We provide secure storage for temperature-sensitive biologics, real-time shipment tracking, and customs documentation management. Certified by TSA and DSCSA, we optimize supply chain efficiency while maintaining compliance with global regulatory standards for high-value medications.
People
Chris Hanks
Founder, Innovation Lab
Entrepreneurship expert with 20+ years leading pharmaceutical logistics innovation. Developed award-winning supply chain solutions and taught business strategy at multiple universities.
Katy Kleinmann
VP Business Development
12-year veteran in international pharma distribution. Fluency in German and French enables direct client relationships across Europe and Africa.
Sonja Probst-Hunczek
Customer Development Director
Molecular biology PhD with expertise in Eastern European and Middle Eastern markets. Oversees compliance with EU Falsified Medicines Directive.
Youngwoo Song
Customer Development Director
Psychology graduate with decade of experience in APAC pharmaceutical markets. Manages logistics for temperature-sensitive biologics shipments.
Questions
What geographic regions do you serve?
We deliver medications to 100+ countries, specializing in Europe, Asia-Pacific, Middle East, and Eastern Europe regions with complex regulatory environments.
How do you handle temperature-sensitive medications?
Our certified cold-chain packaging includes real-time data logging and validated shippers maintaining precise temperature ranges during international transport.
Can you ship controlled substances internationally?
Yes, we hold DEA licenses for CII-CV substances and manage all regulatory requirements for international controlled drug shipments.
What compliance certifications do you maintain?
We're FDA-registered, DEA-licensed, and comply with EU GDP, DSCSA, and FCPA standards for pharmaceutical distribution.
How quickly can orders be processed?
Standard quote responses within 1-2 business days; urgent shipments coordinated immediately with expedited customs documentation.
Do you support clinical research organizations?
Yes, we provide specialized supply chains for multi-country clinical trials including controlled substance management and regulatory compliance.
