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LaunchWorks Team Members in the Lab

Accelerate Your Life Science Product Commercialization Process

Advance your life sciences products for optimized results, no matter the production stage. As a full-service ISO-13485:2016 certified and FDA registered contract manufacturer, LaunchWorks CDMO’s mission is to help you focus on your science by offering a wide range of professional contract services to accommodate your diverse development and commercialization needs.

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How We Support Diagnostics Industries

Discover our suite of services designed to deliver and execute on a successful product manufacturing plan, from design development to large-scale manufacturing to drop-ship fulfillment.

 

How We Achieve Commercial Success

LaunchWorks CDMO is here to help you design your product so it is ready for further development and manufacturing. Work closely with expert scientists and engineers as an extension of your own operations to: 

  • Develop a project plan that meets your commercialization expectations
  • Determine how the product should be designed to maximize utility
  • Identify potential problems in the development process
  • Find materials, processes, or technologies that will be needed for advancement
  • Oversee the on-time manufacturing and delivery of your custom life science products

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Design & Development

Work with an expert design and development team to examine product plans and validate design enhancements that increase efficiency, reduce risk, and improve your end-user experience. 

From initial pilot lot production to lyophilization formulation and assay refinement, your product will be carefully reviewed by the LaunchWorks CDMO team to ensure high quality performance. Design and development services also include a variety of validation study services to determine:

  • Pilot Lot(s) for rapid market ready product
  • Custom formulations and product shelf life
  • Process development to ensure scalability
  • Packaging development, cold chain, and integrity
  • Functional quality control parameters for final lot release

Learn More About Design & Development

Manufacturing: Project Management, Onboarding, & Production

The LaunchWorks CDMO production team will execute a variety of operations required to manufacture your product, such as formulation, manual and automated filling, labeling needs, kit assembly, and final product quality control testing, all in compliance with cGMP and ISO 13485.

With an assigned project manager, your product can make its way to commercialization once the design has been finalized. Your project manager will be by your side, helping you:

  • Manage timelines and ensure on-time delivery
  • Provide detailed progress reports
  • Review labor and automation efficiencies
  • Conduct raw material planning
  • Support vendor management
  • Ensure end-user adaptability after the product is finalized

Learn More About Manufacturing

Fulfillment & Storage

LaunchWorks CDMO is dedicated to continuous improvement of our customer’s biotech products. Let us focus on the distribution of your product so you can focus on your research and lab projects. Our fulfillment and storage services provide an opportunity to: 

  • Order and conduct inventory management
  • Complete kitting services
  • Track product supply
  • Organize carrier logistics and shipping conditions

Learn More About Fulfillment and Storage

The LaunchWorks Process:

Your Product Manufacturing Plan

At LaunchWorks, we understand that your primary goal is to turn your complex life science idea into a reliable and profitable product so that it can get to the market and people who need it. Each Product Manufacturing Plan is customized according to product specifications and your commercial goals to ensure high-quality production through seamless life science manufacturing practices.

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Stage I: Design and Development

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Stage II: Technology Transfer

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Stage III: Precision Manufacturing

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Stage IV: Product Launch and Fulfillment

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Stage V: Post-Launch Efficiencies

See a description of the 5 Stages of the Product Manufacturing Plan

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Who We Work With in the Diagnostic Industry

Our professional development and manufacturing services are an ideal fit for a variety of life science product organizations.

LaunchWorks Team Members in the Lab
If your business aligns with any of the following, we can help you get to market fast.
  • Startup innovators with an initial product idea but no design
  • High volume dry kitting product organizations looking to build fast
  • Life science production is at a design freeze, and you want to avoid high cost investment and build-out for manufacturing
  • Kit production is highly technical and requires specialized equipment and high cost materials
  • Organizations facing technical and planning roadblocks, looking to advance to lot production and release

See Diagnostic Solutions

Lab Manufacturing Resources

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About LaunchWorks CDMO

Our team has been a leading CDMO for the diagnostics industry since 2010.

We are a winning team of innovative, experienced, and knowledgeable contract manufacturing experts with a track record of turning complex life science ideas into high-quality products on-time and on-budget.

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What Customers Say About Our Contract Manufacturing Services

“We went with LaunchWorks because you had the better solution. Every department was very pleased with the partner experience, including operations, R&D and marketing!”
“Your people demonstrated they were excited about the project and wanted to do the work! We also like that you have a culture of continuous improvement and LEAN manufacturing methodologies.”
“Out of three vendors we use, one is cGMP, you have no errors & the others had several.”

Affiliate Companies

Meet the affiliate companies we are proud to work with:

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Integreon

Integreon Global is a family of businesses that provide testing services, packaging and monitoring solutions, novel materials, and contract manufacturing to guarantee the integrity and protection of products used for diagnostics.

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Cryopak

Cryopak is a provider of comprehensive cold chain packaging solutions with a focus on temperature-controlled packaging.

 

 

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DDL

DDL has been serving the medical industry for more than 30 years with an extraordinary full-service package, product, and materials testing lab.

 

 

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NexKemia

NexKemia develops techniques to integrate customizable expandable polystyrene (EPS) resin formulations through the advancement of technical expertise as well as using superior production and application engineering approaches.

Reach the Market With Fast, Safe Manufacturing

Finalize your product design. Ramp up your production for on-time delivery. Improve efficacy of new product iterations. No matter the stage you’re in, the LaunchWorks CDMO team is ready to help you.