FULL-SERVICE DEVICE & COMPONENT CDMO
Your single partner.
From concept to
commercialization.
Alentra unites development and manufacturing to help medical, pharmaceutical, and diagnostic innovators move complex programs into production with confidence.
ISO 13485:2016 • FDA Registered • U.S.-based, coast to coast
THE ALENTRA DIFFERENCE
One full-service CDMO.
Fewer handoffs.
Alentra connects design, DFM, tooling, molding, cleanroom manufacturing, assembly, packaging, and logistics through one accountable team. With every capability working together, critical program knowledge stays connected, handoffs are reduced, and issues can be addressed earlier—giving you greater continuity, control, and momentum from one stage to the next.
Why teams choose Alentra
Engineering-led
Degreed, in-house engineers on your program for its full lifetime.
Single-source
Every plastic component designed, tooled, molded, and assembled in one location.
Quality-first
A zero-error Quality Policy and Statistical Process Control on every build.
U.S.-based
Coast-to-coast facilities and warehousing for a resilient supply chain.
CONCEPT TO COMMERCIALIZATION
The full lifecycle, one
accountable team
Our capabilities follow your program's lifecycle — so a single, accountable team carries your device from a first sketch to the loading dock.
1
Design & Development
Concept, feasibility, DFM, and prototyping with in-house engineers.
2
Tooling
In-house & U.S./APAC hybrid tool builds, monitored 24/7.
3
Molding
In-house & U.S./APAC hybrid tool builds, monitored 24/7.
4
Automation & Assembly
Ultrasonic welding, bonding, kitting, and automation integration.
5
Post-Molding & Logistics
Labeling, inspection, sterilization, warehousing, and shipping.
FIND YOUR PATH
Tell us how you think about your program.
Whether you’re looking for a specific capability or a partner with experience in your market, we’ll help you find the expertise relevant to your program.
EXPLORE BY CAPABILITY
Do you have the capabilities my program needs?
From micro molding and 5+ liter blow molding to in-house tooling, automation, and assembly, explore the capabilities that can support your program from development through production.
View all Capabilities
EXPLORE BY Market
Do you understand my
industry?
We understand the requirements of regulated healthcare and consumer markets, with relevant applications, manufacturing capabilities, and quality expertise for each.
View all Markets
MARKETS WE SERVE
Deep expertise for markets
where precision matters most.
Six distinct markets. One experienced partner with the engineering, manufacturing, and quality capabilities to support each.
Medical Device
Components manufactured to precise specifications under a zero-error Quality Policy and Statistical Process Control.
Explore Market
Drug Delivery
Autoinjectors, pens, and single-use consumables at the precision and scale these programs demand.
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Diagnostic
Cartridges, reagent and labware, and high-volume single-use consumables — including microfluidics.
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Pharmaceutical
Media bottles, dosing containers, closures, and multi-layer PET, HDPE, and PP vials.
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Life Science
Pipettes, blood-testing components, media bottles, and bioprocess SUS/SUT consumables.
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Consumer & Packaging
Personal care, food & beverage, and hospitality — from mouthwash bottles to dispensers — with the finish and consistency retail demands.
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Have a program that spans markets or requires a specialized approach?
WHY ALENTRA
Confidence comes from control at every critical stage.
One team from concept to qualification
A dedicated project manager and cross-functional team guide your program through DFM, tooling, process engineering, validation, and qualification—preserving critical knowledge and maintaining continuity from development through production.More control over tooling
On-site machining, integrated tooling support, and flexible domestic and US/APAC sourcing options keep critical tooling decisions closer to your program. Tools are monitored around the clock to support scheduled preventive and predictive maintenance, helping resolve issues faster, protect uptime, and keep production ready.Quality built into the process
Quality is integrated from development through production with an ISO 13485 quality management system, FDA registration, specialized inspection, and IQ/OQ/PQ qualification support. This connected approach helps verify processes, maintain compliance, reduce program risk, and move products into production with greater confidence.
ALL CAPABILITIES
Every capability
working together
Know what you need to built?
PROOF IN PRACTICE
Real programs.
From concept to successful launch.
Easy tool extraction device
Molding and advanced prototyping supported the device from early concept through development and successful launch.
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Swab device
Streamlined design, advanced mold construction, and inline part inspection created a more controlled path from development into production.
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Reagent buffer bottle assembly unit
Injection and blow molding, assembly, RFID integration, labeling, and kitting were coordinated through one integrated program.
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Easy tool extraction device
Molding and advanced prototyping supported the device from early concept through development and successful launch.
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Your program could be next.
INNOVATION
Capabilities that set us apart.
Specialized technologies and services that help solve complex product development, manufacturing, and commercialization challenges.
Micro molding & microfluidics
Micro-molded parts as light as 0.001 g and as small as 0.100 inches in diameter, with microfluidic chip manufacturing.
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RFID & NFC
UHF inlays, NFC tags, and IC integration bring connected functionality directly into molded components.
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3D printing & prototyping
3D-printed prototypes and single-cavity development help prove part function and optimize the manufacturing process.
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Sterilization solutions
Sterilization solutions spanning steam, EtO, gamma, e-beam, and chlorine dioxide, supported by validation process management.
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Facilities & CAPACITY
U.S. capacity, coast to coast.
With manufacturing and warehousing across the East and West Coasts, Alentra gives programs access to domestic capacity closer to the markets they serve. Anchored by our Auburn, NY operations, our U.S. footprint supports molding, cleanroom manufacturing, assembly, and logistics—helping strengthen supply continuity and keep programs production-ready.
6
Manufacturing Facilities
7
ISO-certified cleanrooms
167
Molding Machines
5
Coast-to-coast Warehouses
Ready to move your next program forward?
Whether you’re in early concept, tooling, validation, or scale-up, we’ll bring together the expertise and capabilities your program needs for its next stage.
QUALITY & COMPLIANCE
Quality systems built for
regulatory confidence.
In regulated markets, quality has to be more than a claim. Our ISO 13485 quality management system, FDA registration, validation services, and inspection capabilities provide documented support from development through production.
- ISO 13485:2016 quality management system
The core medical-device quality standard, with downloadable certificates. - FDA registered & 21 CFR Part 820 / QMSR aligned
Ready for regulated device production and inspection. - IQ / OQ / PQ validation services
Process validation and qualification integrated into development. - Zero-error Quality Policy & Statistical Process Control
Full-dimensional and on-floor inspection with weekly reporting.
RESOURCES
Insight for every stage
of your program.
Get the engineering brief.
Occasional insight on molding, DFM, materials, and quality — no noise.
COMMON QUESTIONS
What program teams need to know first.
Let's build your next device.
Tell us about your program and we'll map the fastest, lowest-risk path
from concept to launch.