Clinical & Laboratory Diagnostics Solutions
Reliable, Compliant, and Scalable Diagnostic Kit Fulfillment
Clinical laboratories and diagnostic manufacturers rely on precision, compliance, and efficiency to deliver accurate results. Every specimen collection kit must meet strict FDA and ISO 13485 requirements while ensuring seamless lab integration and sample integrity. WellPact helps CLIA-regulated laboratories maintain compliance and efficiency by providing precisely assembled, lab-ready specimen collection kits. Our expertise in regulatory-compliant packaging and logistics ensures accurate sample processing without delays or errors.
End-to-End Fulfillment for Clinical & Laboratory Diagnostics
WellPact partners with clinical laboratories, diagnostic manufacturers, and biotech companies to provide custom specimen collection kit assembly, regulatory-compliant packaging, and secure return logistics. Our expertise ensures that every diagnostic kit is designed for efficiency, accuracy, and reliability—so labs can focus on delivering results with confidence.
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Assemble and package protocol-specific specimen collection kits with study-compliant components, labeling, and documentation.
Custom
Clinical Trial Kit Assembly
Provide prepaid return logistics, real-time tracking, and secure chain of custody to protect sample integrity.
Sample Return & Chain of Custody Management
Operate under FDA-registered, ISO 13485-certified kitting and fulfillment processes to support GCP, IRB, and trial sponsor requirements.
Regulatory & Quality Compliance
Maintain lot control, expiration monitoring, and serialized inventory tracking for full traceability.
Inventory & Expiration Tracking
Ship trial kits directly to patients’ homes or clinical sites, supporting decentralized and site-based study models.
Direct-to-Patient
&
Site Distribution
Support pilot studies, multi-site trials, and global research initiatives with scalable, flexible fulfillment.
Scalable & Adaptive Fulfillment
Why WellPact?
Clinical and laboratory diagnostics require a fulfillment partner with expertise in regulated healthcare logistics, sample integrity, and compliance-driven fulfillment. WellPact ensures that every diagnostic kit is built to your exact specifications, integrates seamlessly into lab workflows, and meets strict regulatory requirements.
We provide the precision, scalability, and quality control labs need to ensure accurate specimen processing and compliance. Our expertise in temperature-controlled packaging, specimen tracking, and regulatory-driven fulfillment makes WellPact the trusted partner for clinical and diagnostic testing programs.
Comprehensive Diagnostic Kit Fulfillment Solutions
How WellPact Supports Your Diagnostic Testing
Component Sourcing &
Procurement
Source and integrate lab-approved collection devices, specimen transport materials, and compliant packaging to meet regulatory and operational needs.
Custom Kit Assembly &
Packaging
Precisely assemble specimen collection kits to exact specifications, ensuring sample integrity and regulatory compliance.
Regulatory
&
Quality Compliance
Maintain FDA-registered, ISO 13485-certified kit assembly and fulfillment, supporting CLIA-regulated testing with expiration tracking, lot control, and serialization for full traceability.
Chain of Custody
&
Secure Return Logistics
Enable secure, traceable specimen handling with unique sample labeling, tamper-evident packaging, and compliant return logistics.
Temperature-
Controlled Packaging &
Compliance
Package diagnostic kits for ambient, refrigerated, and frozen transport, using insulated shippers, gel packs, and dry ice-compatible solutions for compliance and sample protection.
Scalable Inventory
&
Distribution
Manage inventory and fulfillment for small-batch research kits to high-volume clinical diagnostic programs, adapting to demand fluctuations.
Data Security
&
HIPAA Compliance
Ensure secure handling of patient data and chain of custody tracking to maintain compliance and audit readiness.
Project Request & Scoping
Understand mission objectives & intended use for kits. Define goals, requirements budget, and timelines.
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Sourcing & Procurement
Create kit BOMs. Source materials or receive customer supplied items.
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Custom Kit Assembly &
Quality Control
Assemble kits with precision, ensuring quality through serialization, lot tracking, and
rigorous quality checks.
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Fulfillment & Logistics
Coordinate efficient shipping to locations or end-users with secure tracking and manage
prepaid return logistics for specimen kits when needed.
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Inventory Management & Warehousing
Store kit materials and preassembled kits in secure facilities, forecast demand, and
enable rapid access.
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Data Tracking & Reporting
Ensure traceability by integrating tracking data with customer systems and provide
detailed reports on kit deployment, usage, and returns as needed.
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Continuous Improvement & Feedback
Conduct post-project reviews with customer stakeholders and refine processes based on
outcomes and feedback.
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Clinical & Laboratory Diagnostics Solutions
WellPact ensures compliance, accuracy, and efficiency with expertly assembled specimen collection kits, meeting FDA and ISO 13485 standards for seamless lab integration.
