Our Warehousing and Distribution services ensure regulatory compliance and product integrity for the Life Science supply chain, whether your needs involve commercial pharmaceutical samples, finished goods or ancillary materials.

 

Ensuring Regulatory Compliance and Product Integrity

We are fully aware of the significant, non-negotiable requirements when working with pharmaceutical products and materials. Examples include temperature management to protect product integrity, mandated licenses and certifications, systems and processes that conform to regulatory guidelines, and end-to-end security of the supply chain.

Everyone must comply – from the smallest biotech developing its first therapy to the largest global pharmaceutical manufacturer with multiple major brands.

As your strategic partner, we have the experience and expertise to serve your warehousing and distribution needs with outstanding accuracy, security and efficiency, while meeting all regulatory and other requirements.

Our distribution centers are strategically located in southern New Jersey, and in Memphis, Tennessee, a major logistics hub for the United States. These facilities are highly secure and fully climate controlled, featuring:

  • A validated Warehouse Management System
  • cGMP, GDP, PDMA and Drug Supply Chain Security Act (DSCSA) compliant processes
  • Wholesale distribution licenses
  • DEA Class III – V, TSA and VAWD certification
  • Designated areas for quarantined/high-level security storage
  • Managed environments for ambient (15°C to 30°C), refrigerated (2°C to 8°C) and frozen (-25°C to -10°C) storage

We ensure optimal quality and capacity at our flagship Memphis facility by using advanced automation, including pick-to-light/put-to-light systems and radio frequency technology. We have responded to increased demand for cold chain services – including for complex biologics – by investing in expansion of refrigerated/frozen storage and in providing zero Time Out of Environment (TOE) pick and pack services.

Whether managing commercial pharmaceutical samples, finished goods, or ancillary materials, we have a proven track record of delivering industry-leading service with impeccable quality standards.

 

Customized Fulfillment Processes for Commercial Distribution

When defining their commercialization strategy, manufacturers understand that a one-size-fits-all distribution approach no longer works when it comes to specialty drugs and devices. They require their trade partners to have flexibility to customize fulfillment processes, and to provide cost effective distribution programs that include services such as end-to-end temperature management.

Patheon logistics trade distribution solutions coupled with our sample distribution expertise provides a full suite of services to help support our clients’ product commercialization needs once approved for use.

We specialize in creating distribution models tailored for high risk, high value pharmaceutical products. Whether dealing with prescription drugs or sensitive medical devices, we design a program that specifically meets our clients’ needs.

Our facilities and their teams of fulfillment experts have the capacity and expertise required to manage the challenges associated with finished goods that require specialized attention from time of receiving through outbound shipment.

To ensure end-to-end product integrity, our logistics experts will design an optimized transportation plan to manage distribution through final delivery. Key elements include:

  • Licenses & Certifications
    • cGMP, GDP, PDMA & DSCSA compliant
    • Licensed to distribute prescription drug products to every state
    • Wholesale Distribution Licenses
    • DEA registered and licensed to receive, store and distribute C III – V controlled substances
    • Verified Accredited Wholesale Distributors (VAWD) certified
  • Inventory Management
    • Validated Warehouse Management System
    • Item-level serialization
    • On-line visibility to order and shipment status
    • System-to-system interfaces proactively communicate product availability
  • Controlled Temperatures
    • Controlled ambient (15°C to 25°C)
    • Refrigerated (2°C to 8°C)
    • Frozen (-20°C)
    • Dry ice (-80°C)
    • Ultracold (LN2)
  • Distribution Expertise
    • Optimized transportation plans
    • Air, ground and parcel service
    • Final mile delivery
    • White glove services

 

A Market-Leading Provider for Sample Fulfillment and Distribution

We are a market-leading provider of Direct to Representative (DTR) and Direct to Practitioner (DTP) sample fulfillment and distribution services. Our best practice-based suite of services provides the flexibility our clients require while maintaining compliance with exacting standards.

 

Best-in-Class Direct-to-Rep and Practitioner Sampling Solutions

For over 30 years, Life Science companies have partnered with us for commercial sample distribution because of our logistics expertise and unmatched track record of delivery to representatives in the field or directly to healthcare practitioners.

We are the industry leader for the delivery of samples, sending materials direct to practitioners and to pharmaceutical representatives, managing the largest sample-send programs in North America. We facilitate over 8,500 daily Life Science shipments, including DEA controlled substances and cold chain product, and have managed over 3 million annual direct-to-practitioner shipments with over 53 million individual product units picked.

We deliver performance that exceeds expectations—supporting as many as 20,000 DTR shipments per month with time-definite white-glove delivery service, 3 million DTP shipments annually with over 53 million individual product units picked, all with a pick accuracy over 99.9%, 99%+ on-time service and 99% of shipments delivered without damage or loss.

Our processes reflect best practices that we share with our clients to streamline implementation and maximize quality and compliance. We offer standardized templates for Sample Request Forms, data exchange file layouts and Representative/Practitioner alerts and correspondence. Orders are validated against a comprehensive list of configurable rules. Our client web portal provides convenient access and end-to-end visibility to in-process orders and operational reports, and our OnTheGo℠ suite of mobile app and web-based services optimizes sales representative productivity and enhances practitioner convenience. As part of our quality and service culture, we continue to refine these solutions to meet our clients’ needs. Areas of focus include:

  • Quality & Compliance
    • cGXP, PDMA & DSCSA compliant processes
    • Validated warehouse management system
    • Signature audits and AOC follow up
    • End-to-end visibility and reporting
  • Optimized Transportation
    • Strategically-located distribution centers
    • Order consolidation
    • In-territory shipment re-directs
    • Integrated returns processing
  • Sales Rep Productivity
    • Exact, 1 & 2 hour delivery appointments
    • Reminder notices
    • White glove delivery
    • Dunnage removal
  • Practitioner Convenience
    • Preferred day and time of delivery
    • Electronic sample request forms
    • On-site electronic acknowledgement of contents

 

Sample Compliance Services: Supporting Your Sample Accountability Programs

The regulatory environment governing pharmaceutical product and, in particular, prescription drug sampling, demands comprehensive sample accountability programs. As a leading supplier of sample fulfillment and distribution services, the Patheon logistics team collaborates with our clients to provide complementary services in support of these programs.

We understand the extraordinary risk and exposure pharmaceutical manufacturers assume when sampling prescription product, especially those that are DEA controlled substances or requiring a cold supply chain. Our Client Services team and call center serve as a dedicated point of contact, coordinating critical follow up services to ensure compliance with industry and client standards.

We support our clients sample compliance needs with services that include Sample Allocation Management, Acknowledgement of Content (AOC) follow-up, Signature Audit programs, and Representative Closeouts and Field Audits.

Our PDMA/Drug Supply Chain Security Act (DSCSA)-compliant services help minimize risk of non-compliance through strict adherence to detailed Standard Operating Procedures (SOPs), by providing constant status communication with our clients and, where needed, electronic interfaces with their strategic partners. Important steps include:

  • Sample Allocation Management
    • Define and update allocations
    • Employ flexible date schemes
    • Adjust allocations across territory hierarchy
  • Acknowledgement of Contents
    • Standard exception reporting
    • 30-, 60- and 90-day follow ups
    • OnTheGo℠ AOC mobile app to facilitate processes
  • Signature Audits
    • Annual audit of all representatives
    • Letters released to HCP for review
    • Negative response follow through
    • Ongoing reporting of results
  • Representative Closeouts and Field Audits
    • Detailed asset inventory by professional, PDMA-trained agents
    • Coordinated return of samples and company assets

Contact us to learn more about our warehousing, distribution, and other global logistics services.