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Nelson Laboratories, LLC Company Profile

 

 
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http://www.nelsonlabs.com
E: [email protected]
T: (801) 290-7500
F: (801) 290-7998

Address
6280 S. Redwood Rd., Salt Lake City, UT, 84123, United States
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Qualifications: FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows

Markets Supplied: North America, Europe

 

Nelson Labs, a Sotera Health company, is the industry-leading global provider of lab testing and expert consulting services. We perform microbiological and analytical laboratory tests across the medical device, pharmaceutical, and tissue industries. The company is regarded as a best-in-class partner with a strong track record of collaborating with customers to solve complex issues.

With the addition of Nelson Labs Europe, we are the leading global extractables and leachables lab testing platform. We have over 700 scientists, technicians, and service specialists who diligently performing more than 700 rigorous tests in 13 global laboratory locations. With decades of expertise, we stand behind the quality of our results and the strength of our customer partnerships.

Why Choose Nelson Laboratories

Every year, hundreds of medical device, pharmaceutical, and tissue companies make Nelson Labs their testing laboratory of choice. For them, the decision is easy. Nelson Labs is a clear leader in the microbiology testing industry, offering more than 700 laboratory tests and employing more than 700 scientists and staff in state-of-the-art facilities. We are known for exceptional quality and rigorous testing standards, but it’s our focus on the bigger picture that sets us apart. We look beyond test results and partner with you to achieve your long-term business goals — mitigating risk, being first to market, and succeeding with your customers.

Companies choose Nelson Laboratories for our:

  • Thought leaders and approachable experts. We give you direct access to industry authorities who understand your business and add value every step of the way.
  • Customer-centric culture. We take the time to understand your vision. Your goals become our goals.
  • Real-time project management tools and a dedicated client portal. We provide proactive information, keeping you informed and in control.
  • Metric-driven testing processes. We're our own toughest customer, holding ourselves to goals exceeding 99% for things that matter most to you, like quality, turn-around time, and testing accuracy.
  • Global compliance expertise and support. We act as a trusted advisor, helping you navigate the ever-changing compliance landscape.

See how we can help you mitigate risk, be first to market, and succeed with your customers.

Quick Facts
Founded:
  • 1985 by Dr. Jerry R. Nelson and Lynda S. Nelson
Global Employees:
  • 800+ with more than 700 scientists

  • 75+ registered and specialist microbiologists (NRCM)

Global Capacity:
  • 13 global lab sites in the US, Mexico, Europe and China
Headquarters:
  • Salt Lake City, UT
Capabilities:
  • More than 700 microbiological and analytical tests
Committee Memberships:
  • ASTM, ISO, AAMI, ANSI, IEST, PDA, AATB, and more
Certifications:
  • Nelson Labs facilities are FDA-registered as a GMP, GLP, and GTP testing lab with ISO 17025 accreditation
Testing Categories
Medical Device Testing

Getting ready to launch a medical device? Nelson Labs will help you ensure your product meets Federal requirements and validate your product claims. Working with Nelson Labs gives you access to in-depth testing expertise, innovative testing techniques, and world-class facilities and equipment – all designed to help you get your products to market faster and minimize risk. Learn about the wide range of tests we offer for facility validation, raw materials screening, sterilization and packaging validations, biocompatibility, cleanroom and isolator facilities, routine quality control tests, and reusable device studies .

Pharmaceutical Testing

Working on the next pharmaceutical breakthrough? Trust Nelson Labs to help you navigate the maze of complicated testing requirements and deliver the actionable test data you need to get your product on the market. With Nelson Labs you’ll get more than a testing partner that specializes in an impressive number of pharmaceutical tests, you’ll get a partner that understands the unique requirements of your business and industry. Make our team your team for filter validations, facility validation, disinfectant studies, container integrity studies, preservative effectiveness studies, cleanroom and isolator facilities, antibiotic potency assays, sterilization and packaging validations, and routine quality control tests.

Tissue Testing Services

Need to comply with tissue regulations? With the implementation of current good tissue practices (CGTP), tissue banks need to consider many types of validation and routine testing. Nelson Labs can help you comply with the new regulations with a variety of processed tissue validations and tests. Put our years of experience working with tissue banks and related industries to work for you and let us create validations and implement process controls that fit your exact needs.

Expert Advisory Services

Nelson Labs Expert Advisory Services offers an unparalleled breadth of MedTech and pharmaceutical experience to help our clients deliver safe and effective products to market. Our Expert Advisory Service encompasses product development, facility and process validation, and product performance testing, as well as regulatory support.

Each expert advisor brings a unique perspective based on years of industry, regulatory, and scientific expertise. By participating in industry groups, actively working on the standards committees (AAMI/ISO/ASTM/PDA), and partnering with a broad range of MedTech and pharma companies on many product types, our experts bring a breadth of experience to each relationship. Although our lab processes over 50,000 projects each year, our expert advisors ensure success for our clients one project at a time.

By focusing on what matters most, we help our clients deliver life-saving products with every test through our value-added advisory approach.

Discovery Team

  • Observation and onsite review of client processes, quality management systems, validation files and product development phase gates.
  • Assessment and needs discovery related to product development to support validation for regulatory compliance and product submissions.
  • Collaborative development of process changes and tailored solutions for continuous product improvement.

Education

  • Onsite and client-specific training related to industry best practices, current regulatory and test guidance.
  • Custom webinars for client training, regulatory updates and product-specific case studies.

Technical Consulting

  • Product design file review and design phase input

  • Facility validations (water systems, environmental and process controls)

  • Test plans, protocols and written justifications for method selection related to:

    • Biocompatibility and material characterization risk assessments (ISO 10993)

    • Sterilization validations (EO/Steam/Radiation)

    • Packaging validations (ISO 11607)

    • Reusable and reprocessed devices (AAMI TIR 12/30)

    • Product-specific validations and failure investigations

    • Development and review of product IFUs/DFUs

    • Product or family groupings

    • Unique process validations

  • Regulatory support for submissions, product changes, detentions or rejection notices.

Ask an Expert

If you have a challenging testing question, we have an answer. Our approachable experts are always happy to respond to your questions. They know how to effectively communicate with anyone – regardless of testing background. Get to know our industry-recognized scientists and their areas of expertise. Use the form below to select your expert and submit your question.

Education

We believe in the power of education. That’s why we’ve created numerous opportunities for you to fine-tune your skills or learn something new. If you can’t get away from the office, register for a webinar and get helpful, relevant information from the convenience of your desk. If you are on the road, join us at one of our seminars for in-person training or find out at which industry events we’ll be presenting.

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Nelson Laboratories, LLC

http://www.nelsonlabs.com
E: [email protected]
T: (801) 290-7500
F: (801) 290-7998

Address
6280 S. Redwood Rd., Salt Lake City, UT, 84123, United States
View map

Follow  
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Espergaerde, Denmark
Aa. Louis-Hansens Alle 11
Espergaerde
3060
Denmark
T +45 (0) 49 12 79 72

Gibraltar Laboratories, Fairfield, New Jersey, USA
122 Fairfield Road
Fairfield, NJ
07004-2405
United States
T (973) 227-6882

Itasca, Illinois, USA
1500 W. Thorndale Ave
Itasca, IL
60143
United States
T (630) 285-9121

Mexico City, Mexico
James Watt No. 22
Cuautitlan Izacalli
Mexico
CP 54730
Mexico
T + 52 (55) 2620 9076

Nelson Labs Europe – Leuven, Belgium
Romeinsestraat 12
Leuven
3001
Belgium
T +32 (0) 16 40 04 84

Ontario, California, USA
687 S. Wanamaker Avenue
Ontario, CA
91761
United States
T (909) 969-2302

 

Nelson Laboratories, LLC

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