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Why
WellPact is a mission-driven organization committed to creating meaningful employment opportunities in rural Pennsylvania while delivering exceptional value to our stakeholders. From our customers and employees to the end-users who rely on our solutions, we’re passionate about making a positive impact on health and well-being through every service we provide and every well-packaged kit we deliver.
Healthcare-Focused Expertise, Built for You
Tailored solutions with a deep focus on healthcare logistics and regulatory needs.
Compliance at Our Core—ISO 13485, FDA, HIPAA
Operating with strict regulatory compliance for safety and quality.
More Than Logistics—A True Partner or (Strategic Support Beyond Logistics)
Strategic support in kit fulfillment and supply chain optimization, every step of the way.
Flexible Solutions, Seamlessly Integrated
End-to-end or modular services with integrated tech for smooth, scalable operations.
Healthcare-Specific
Expertise
Exclusively focused
on regulated
healthcare
environments, with
deep understanding
of industry workflows,
compliance, and
logistics.
Operational
Scalability
From pilot projects to large-scale national rollouts, we adapt to meet your program’s needs. Whether delivering small
batches or scaling to 100,000+ kits, we ensure reliable execution within defined timelines.
Fully Customizable
Solutions
Tailoring every aspect of our services—from kit design to logistics and compliance—to
align seamlessly with your program requirements and
ensure operational success.
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Comprehensive
Tracking &
Integration
Barcoding, tracking, and
scanning ensure complete traceability of every kit. We integrate seamlessly with your
systems, delivering the data and insights needed to align with
your operational processes.
ISO 13485 & FDA Compliance
Meeting regulatory standards isn’t optional. Our processes are built to comply with ISO 13485 (the international standard for medical device quality management) and FDA regulations, ensuring that every kit meets the highest standards for safety and reliability.
Ensuring Compliance, Accuracy, & Complete Traceability
Why Tracking, Serialization, and Compliance Matter for Your Business
In healthcare, accuracy isn’t just important—it’s critical. Every kit, test, and medical component must be accounted for to ensure patient safety, regulatory compliance, and operational efficiency. That’s why WellPact has built a system that tracks every piece of a kit from the moment it’s assembled to when it reaches the patient and beyond.
Lot Tracking & Expiration Management
ThisEvery medical component has an expiration date. If outdated materials get used in a test, the results may be unreliable or even dangerous. Our system tracks expiration dates and ensures only valid, high-quality components are used.
Barcode & Serial Number Integration
Each kit and its components are assigned unique serial numbers and barcodes. This means if there’s ever an issue—like a recall on a swab or reagent—we can pinpoint exactly which kits contain the affected component and take immediate action.
Full Visibility & Recall Readiness
If a supplier issues a recall, you need to act fast. With WellPact, you’ll know exactly which kits are impacted, where they are, and who received them—eliminating guesswork and protecting patients.
Patient-Level Tracking
Our system links shipping details, test taker ID, and barcode data together. This ensures that every test result is tied to the correct patient, reducing errors and ensuring compliance with regulatory requirements.
ISO 13485 & FDA Compliance
Meeting regulatory standards isn’t optional. Our processes are built to comply with ISO 13485 (the international standard for medical device quality management) and FDA regulations, ensuring that every kit meets the highest standards for safety and reliability.
WellPact's Commitment to Healthcare Logistics and Our Focus on Solving Industry Challenges.
At WellPact, we understand that healthcare logistics are far from simple. That’s why we’ve designed our services to go beyond just moving products—our solutions are built to solve the unique challenges of healthcare fulfillment. Whether you're managing regulatory compliance, scaling your supply chain, or optimizing operational efficiencies, WellPact is here to guide you every step of the way.
ISO 13485 Certified
Meeting the Highest Standards in Healthcare Fulfillment
WellPact operates under an ISO 13485-certified Quality Management System, the globally recognized standard for medical device fulfillment. This certification reflects our commitment to:
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Stringent quality control measures
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Risk management and regulatory compliance
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Continuous improvement in processes to meet evolving healthcare needs
Our adherence to ISO 13485 ensures that every product we handle meets the highest quality and safety requirements, reducing risk and enhancing reliability for our partners.
What is ISO 13485?
ISO 13485 is the global benchmark for medical device quality management systems (QMS). It sets requirements for:
✔ Risk-based approach to fulfillment and distribution
✔ Process consistency to maintain quality across all operations
✔ Regulatory compliance to meet FDA and global standards
✔ Continuous improvement through regular audits and process refinement
How WellPact Implements ISO 13485
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End-to-end traceability: Every step of the fulfillment process is documented, ensuring compliance and accuracy.
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Standardized operating procedures (SOPs): Clearly defined workflows reduce errors and ensure consistency.
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Rigorous quality checks: From incoming product inspections to final shipment verification, we maintain the highest standards of accuracy and reliability.
By adhering to ISO 13485, we help our partners mitigate risk, improve efficiency, and ensure patient safety.
Why ISO 13485 Matters for Your Business
✔ Minimized Risk: Reduces errors, recalls, and compliance issues.
✔ Enhanced Product Quality: Ensures reliable and accurate products.
✔ Increased Client Trust: Signals a commitment to excellence.
✔ Regulatory Confidence: Keeps you audit-ready with thorough documentation.
✔ Operational Excellence: Improves efficiency, accuracy, and fulfillment speed.
✔ Market Trust & Credibility: Builds credibility with stakeholders.
FDA-Registered Facility
Compliant & Reliable Healthcare Fulfillment
WellPact operates an FDA-registered facility, ensuring compliance with regulatory requirements for handling medical and healthcare-related products. Our adherence to Good Manufacturing Practices (GMP) and regulatory guidelines safeguards product integrity from storage to delivery.
As an FDA-registered facility, WellPact operates within strict regulatory guidelines to ensure compliance with medical and healthcare product handling requirements.
Our FDA registration provides assurance that your healthcare fulfillment operations are handled with the highest level of safety, accuracy, and compliance.
✔ Compliance with Good Manufacturing Practices (GMP)
✔ Proper storage, handling, and distribution of healthcare products
✔ Stringent environmental controls to protect product integrity
✔ Regulatory oversight to maintain compliance with healthcare standards
24/7 Surveillance:
High-resolution security cameras monitor all warehouse and operational areas.
Controlled Badge Access:
Only authorized personnel can enter secure areas, preventing unauthorized handling.
Visitor Management System:
All visitors must check in, receive authorization, and be escorted at all times.
Security Logs & Audit Trails:
Every access point is monitored and logged for traceability and compliance.
Facility Security & Controlled Access
Protection at Every Level
We understand that security extends beyond data—it’s about protecting every aspect of the fulfillment process, from inventory to shipment. These measures guarantee that every product, order, and piece of data is handled with the highest level of protection.
To maintain a secure fulfillment environment, WellPact enforces strict facility access controls, including:
Packaging & Shipping Services
Precision Shipping & Scalable Distribution
Our state-of-the-art fulfillment center is equipped with the latest automation and quality control technologies to optimize efficiency while maintaining the highest standards of accuracy and compliance. We handle custom packaging, labeling, and lot tracking, ensuring product integrity and security at every stage. With our integrated sample tracking solutions, we make it easy for healthcare companies to maintain compliance, reduce errors, and ensure patient safety.
Bulk Distribution
Custom Packaging
Direct-to-Patient and Provider Shipping
Eco-Friendly Materials
Real-Time Tracking & Visibility
Tamper-Evident &
Compliance Packaging
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Regulatory & Quality Compliance
WellPact's advanced fulfillment capabilities provide complete traceability of every component within a kit—ensuring the highest standards of safety and reliability for healthcare, diagnostics, and life sciences organizations.
HIPAA-Compliant Data Handling
Our systems and processes are designed to meet HIPAA privacy and security standards, protecting patient information at all levels.
Encrypted Systems
All data transmissions, records, and transactions are encrypted to prevent unauthorized access.
Access Controls
Only authorized personnel have access to sensitive patient and healthcare data.
Secure Data Handling Protocols
Our team follows strict guidelines to maintain compliance with healthcare privacy standards.
Secure Storage & Transmission
We implement strict security measures for handling and transmitting sensitive healthcare information.
Routine Security Audits
Regular testing and assessments ensure our systems remain secure against emerging threats.
Compliance with Healthcare Privacy Standards
We ensure that our partners’ data remains protected, confidential, and compliant.
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WellPact's advanced fulfillment capabilities provide complete traceability of every component within a kit—ensuring the highest standards of safety and reliability for healthcare, diagnostics, and life sciences organizations.
Quality Management
Precision, Consistency, and Compliance
At WellPact, we take a proactive approach to quality. Our Quality Management System (QMS) is designed to ensure accuracy, consistency, and compliance at every step of the
fulfillment process.
Quality is at the core of everything we do. Our robust Quality Management System (QMS) includes:
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Standardized operating procedures (SOPs) to maintain consistency
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Regular audits and performance monitoring to drive continuous improvement
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Documented training programs to uphold compliance at every level
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We regularly assess our processes, identifying areas for improvement to enhance efficiency and accuracy.
Quality Control Checks
Audits & Performance Monitoring
Our teams receive continuous education on compliance, quality control, and best practices.
Compliance Assurance
Ongoing Training
Every fulfillment step follows documented SOPs to maintain consistency.
Standardized Processes
Quality Management
At WellPact, quality is not an afterthought—it’s built into every process. Our comprehensive Quality Management System (QMS) ensures that every product, order, and shipment meets the highest standards.
Our Quality-First Approach
Quality Management
Precision, Consistency, and Compliance
If an issue arises, we take proactive measures to correct it and prevent recurrence.
Corrective & Preventive Actions (CAPA)
HIPAA Compliance & Data Security
Protecting Sensitive Healthcare Information
In healthcare fulfillment, data security is just as critical as product quality. WellPact is committed to HIPAA compliance, ensuring that all protected health information (PHI) is handled securely and in accordance with federal privacy regulations.
Our Approach to Data Security & Compliance
✔ ISO13485-Certified Processes – Ensuring full regulatory compliance for healthcare logistics.
✔ Inventory Tracking & Automation – Providing full visibility and control over stock levels.
✔ Scalable Solutions for Growth – Supporting small-scale and high-volume fulfillment needs.
Why Choose WellPact for Medical Kit Assembly?
A: Yes! We tailor every kit to your specifications, sourcing components or integrating customer-supplied materials.
Q: Can you assemble fully customized medical kits?
A: Every kit undergoes multi-point quality checks, serialization tracking, and process validation to ensure accuracy.
Q: How do you ensure kit accuracy and completeness?
A: Yes! We offer scalable assembly solutions to meet both small-batch and high-volume production needs.
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Let’s Build the Perfect Medical Kits Together
From sourcing to final packaging, WellPact ensures your medical kits meet the highest standards of quality and compliance.
Why WellPact
We are 100% committed to healthcare, which means we’re designed specifically to meet the unique demands of this industry.
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Tailored solutions for the complexities of healthcare fulfillment.
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In-depth understanding of regulatory requirements and industry standards.
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Expertise in managing sensitive, high-value, and time-critical shipments.
Exclusive Focus in Healthcare
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WellPact isn’t just a third-party logistics provider. We’re your strategic partner, providing hands-on support across your entire supply chain.
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End-to-end solutions or modular options tailored to your needs.
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Strategic insight into kit fulfillment, inventory management, and supply chain optimization.
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Long-term partnerships that evolve as your business grows.
More Than a 3PL—A True Healthcare Partner
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Compliance is in our DNA. We know that healthcare logistics are governed by strict regulations, and we take every step necessary to meet those standards.
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ISO13485, FDA, HIPAA-compliant processes built into our operations.
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Trusted partner in managing complex regulatory landscapes.
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Thorough audits and documentation to ensure ongoing compliance.
Unmatched Regulatory Expertise
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Our technology is designed for smooth, effortless integration into your existing systems, ensuring complete transparency and real-time control.
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Real-time inventory visibility for full supply chain transparency.
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API-enabled order tracking and lab connectivity for streamlined workflows.
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Intuitive technology that’s simple to integrate, easy to use.
Seamless Technology Integration
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Why WellPact
No matter where you are in your business journey, we offer the flexibility to scale with you.
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From small pilot programs to large national distribution, we adapt to your needs.
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Customizable services to fit unique operational requirements.
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Scalable solutions that allow you to grow without the headaches of logistics.
Scalable and Customizable Solutions
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We understand the importance of brand integrity. Our white-labeling options ensure that your brand is front and center, with us working behind the scenes.
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Complete control over the customer experience, from packaging to delivery.
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Expertise in maintaining brand consistency in every kit and shipment.
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Discreet, professional handling to protect your brand reputation.
White-Labeling & Brand Protection
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