v021518 Woodfield Distribution, LLC Presentation of Capabilities
About Us • Woodfield Distribution, LLC Provides Integrated Third Party Logistics Services And Value-Added Solutions Empowering the Life Sciences Industry • Established to Provide Unique, Innovative Logistics Support for Healthcare Companies Where Additional Knowledge, Specialization or Outsourcing is Required • Dedicated to the Highest Levels of Service and Quality Assurance for Customers to Improve Efficiency and Reduce Costs
Logistics Services Warehousing and Distribution Reverse Logistics and Regulatory Compliant Product Disposition Temperature Regulated Environments (Cold Chain) Transportation Management
Warehousing • Receiving, Storage and Fulfillment Services • Full EDI Capabilities • Temperature Regulated Environments • Online Web Portal • Inventory and Data • Real-Time Status Management • Customized Reporting • Serialization for Track and Trace Requirements • Rapid Response Time • Transportation and Logistics Solutions • Order to Invoice Processing
Fulfillment Centers • Approximately 320,000 Square Feet in Boca Raton, FL, Pompano Beach, FL, Sugar Land, TX and Dayton, NJ • Meets all Governmental and Regulatory Requirements • Compliant with DSCSA Requirements • Controlled Substance Cages and Vaults • Climate Controlled • Redundant Power Supply • Alarm System and Digital Video Surveillance • Secure Environment • Close Proximity to Air, Rail and Sea Ports
Reverse Logistics Returned Goods Processing • Centralized Return Center • Reconciliation and Valuation • Programs for: Dispensers, Commercial Returns and Manufacturer Bulk Returns • Two-Step Online Process Recall and Withdrawal Management • Notification and Regulatory Support • Lot and Serial Number Traceability Management of Regulatory Compliant Product Disposition • Retail Returns to Bulk Returns
Regulatory Compliant Product Disposition • Ensures Prescription Medications Are Destroyed According To Strict Guidelines • WDSrx Is Licensed By The State Of Florida Department Of Business And Professional Regulation And The U.S. Drug Enforcement Agency (DEA) • Minimize Environmental Impact • Prevent Potentially Dangerous Drugs From Re-Entering Marketplace • Tracking Of Items From Receipt Through Final Disposition • Management Of Complex And Changing Regulatory Requirements • Issuance Of Certificate Of Destruction
Temperature Regulated Environments • WDSrx Temperature Regulated Environments: • Control Room Temperature (CRT) Between 20 And 25 Degrees Celsius With Relative Humidity Of 60% • Refrigerated/Chilled Storage Ranging From 2-8 Degrees Celsius • Frozen Storage at -20 Degrees Celsius • Compliance And Quality Assurance • cGMP Guidelines For Pharmaceutical Cold Chain Logistics Established By The FDA • Multiple Security Systems Record Movement, Temperature, Video And Humidity • Constant And Real-Time Monitoring
Transportation Management • WDSrx Manages Transportation Requirements For Products Originating Domestically And Internationally • Point-to-Point Supervision • WDSrx Is Licensed By The Federal Drug Enforcement Agency As An Importer Authorizing International Shipments Of Controlled Substances (Schedules CII- CV) • Cost Control • WDSrx Is An Independent Pharmaceutical 3PL • The Best Solution To Clients Considering Safety, Efficiency And Cost • Concierge Service • Precise Delivery Windows, Temperature And Security Monitoring, GPS Location, Insurance Claims, Delivery Receipt Confirmations • Distribution Centers In Boca Raton, FL, Pompano Beach, FL, Sugar Land, TX, and Dayton, NJ
Related Services Product Packaging and Labeling DSCSA Serialization Support Services Physician Messaging/ Patient Services Financial Services Management E-Commerce Solutions
Packaging and Labeling • Advanced Oral Solid Dose Packaging Technology Specializing In: • High Speed Bottle Filling for Tablets and Capsules • Blister Packing • Full Range of Secondary Re-Packaging and Re- Labeling Capabilities • DSCSA Compliance: • Item Serialization On All Lines • Quality Systems and Quality Control: • Incoming, In-Process, Finished Goods Testing • Batch Record Review • Validation Processes • Clinical Trial Support and Kitting
DSCSA Serialization Support Services • DSCSA Compliant Packaging and Labeling For Solids, Semi-Solids and Liquids • Services For Non-Serialized Clients To Become Compliant • From DSCSA Compliant ASN Generation To Primary and Secondary Packaging Serialization • Range of Options To Assist Manufacturers When: • Equipment Is Serialized With Delay In Level 4 Solution • Level 4 Solution Implemented With Delay In Equipment Validation • No Level 4 Or Equipment Serialization Solution • Serialized Product But Requires DSCSA- Compliant Advanced Ship Notice (ASN)
Physician Messaging/Customer Support • Physician Messaging And Sample Fulfillment • Patient Assistance Programs • Dedicated Product Specialists • Intensive Training To Maximize Results • Customized Data Solutions • Inbound/Outbound Call Center • HIPAA Compliant • Real-Time Inventory Visibility • License Verification • Delivery To Physician Offices • Promotional Programs • Materials Management
Financial Services Management Invoicing • Receivables Management • Chargeback Processing • Real-Time Customized Reporting • Secure Client Web Portal • Project Management •
E-Commerce Solutions Comprehensive Consumer/Patient Services • Online Ordering • Shipping To Residential Addresses • Delivery Notification And Tracking • Customer Service And Returns • Omni-Channel Convenience • Real-Time Inventory Management • Order-to-Cash Processing • EDI Transfer • ERP Integration •
Compliance • Properly Licensed to Meet Regulatory Requirements: • State Licensed Nationally • DEA Licensed For Controlled Substances (Schedules II-V) • DEA Distributor, Reverse Distributor, Importer and Re-Packager • VAWD Accredited • Validated WMS System (21 CFR Part 11) • DSCSA Regulatory Compliant
Advantages • Confidence Beyond Compliance • Vested Outsourcing Partnership • Advanced Technology For Customized Solutions • Serialization-Ready for DSCSA Compliance • Total Visibility Across the Supply Chain • Increased Revenue Generation • Committed to Meeting the Constantly Changing Regulations Of The Healthcare Industry • Customer Focused Project Management • Exceeding Standards for Quality Assurance and Compliance
Partners Network of Value Added Resources:
Contact Information Boca Raton Center Sugar Land Center South Brunswick Center 951 Clint Moore Road, Suite A 1113 Gillingham Lane, Suite A 15 Stults Road Sugar Land, TX 77478 South Brunswick, NJ 08810 Boca Raton, FL 33487 561.998.3885 phone 281.886.5600 phone 609.642.8513 phone 281.980.7774 fax 609.642.8521 fax 561.998.3886 fax www.WDSrx.com @WDSrx
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