Helping you bring your product to market sooner

The Eurofins Food & Feed Testing over-the-counter (OTC) GMP testing center in Madison, Wisconsin delivers a broad range of harmonized methodologies under Good Manufacturing Practice (GMP) authorization for consumer healthcare product companies. Analyses are performed according to United States Pharmacopeia (USP) or established in-house and verified methods. Our services include (but are not limited to) microbiological, analytical, physical, contamination, and active ingredients testing.

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OTC GMP analytical services

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Eurofins Food & Feed Testing's network of laboratories is your partner in quality OTC GMP Analysis.

Our full-service offering includes:

Analytical services

  • Method development
  • Method verification
  • Method validation
  • Method transfer

Stability studies

  • Accelerated studies
  • ICH conditions
  • Expansive storage capacity
  • Photo-stability

Chemistry testing

  • USP, EP, FCC, ACS (other Global Compendia) Monographs
  • Ingredient and finished product testing
  • Dissolution and disintegration
  • Elemental impurities
  • Residual solvents
  • Viscosity
  • Moisture determination
  • FTIR
  • Organoleptic analysis
  • Physiochemical

Program management

  • Project managers
  • GMP QA oversight study coordinators
  • Study directors
  • Principle investigators
  • Consulting

Regulatory

  • Quality assurance unit
  • GMP compliance
  • GLP compliance
  • 21 CFR parts 210/211
  • ISO 17025 GMP part 210/211 accredited
  • EPA and FDA audited
  • Global and in-country submissions
  • DEA license

Investigative analytical services

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Sampling of services available

  • USP, EP, FCC, ACS (other Global Compendia) Monographs – ingredients, finished products
  • Alcohol (Ethanol/IPA) in products and hand sanitizers by USP <611>
  • Protein, carbon/nitrogen by LECO combustion techniques
  • Investigative analysis
    • Unknown peak identification, forced degradation studies
    • Foreign (unknown) material isolation, identification
    • Ink/packaging migration
    • Off flavor/odor analysis (GCMS, LCMSMS, ICPMS) 
    • Surfactant identification, quantitation including QAC’s “QUAT’s”
    • FD&C dye screen
  • Legal/insurance case support
    • Patent infringement/intellectual property (IP) protection
    • Foreign material, off flavor/odor, detained product, recall Support, product safety opinions
    • Expert witness, courtroom testimony, case planning/strategy
    • Rapid response, independent field sampling anywhere in North America
  • Custom dissolution, disintegration studies

Microbiology services

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  • Ingredient, finished products by USP <61,62>, <2021/2022>
  • Environmental TAMC, TCYM, TAMC (plate/swab) by USP<61>
  • Preservative efficacy, antimicrobial efficacy, challenge studies by USP <51>
  • Burkholderia cepacia testing per USP <60>
  • Purified water testing by USP <1231>
  • Identification bacteria species- VITEK®2
  • Micro-organism ID by custom culturing, 16S metagenomics long sequence speciation
  • Zone of inhibition antibiotic potency by AOAC 957.23, 967.39

Product development

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Work with the experts at Eurofins Product Development and Innovation for all of your product development needs.

Solutions

  • Flavor development
  • Pilot plant services
  • Clinical and consumer trial packaging
    • Dose forms: powders, liquids, tablets, capsules, lotions, creams
    • Package forms: sachets, bottles, cans, blister packs
  • Sensory testing
    • Shelf life
    • Acceptability/palatability testing
    • Packaging appeal
  • Consumer testing 

Instrumentation

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  • Chromatography
    • HPLC/UPLC with UV, RI, ELSD, MS, MS/MS, GC
    • GC with FID, TCD, MS, MS/MS
    • Ion chromatography
  • Elemental analysis
    • ICP-OES, ICP-MS
    • IC-ICP-MS
    • Flame AA
    • LECO with C, H, N
    • EDS, XRD
  • FTIR, Raman, NMR
  • UV/Vis, ELISA 
  • Stability chambers
  • And more

Quality management system

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One quality system

  • Validated software systems and equipment
    • We use state-of-the-art technology and systems to comply with 21CFR Part 11
  • Test methods
    • We determine test suitability per matrix and verify through controls and proficiency testing
  • Measurements traceability
    • Reference standards and materials enable us to establish controls that verify performance
  • Teams
    • Our team members demonstrate a track record of scientific excellence and breadth of industry insights and experience

Why choose Eurofins Food & Feed Testing

  • Material testing against the specification for identity, potency, impurities, physical properties, and stability under strict current GMP (cGMP) compliance
  • Customizable individual programs for the most efficient and quality-focused deliverables
  • Comprehensive testing services for GMP Antiseptic Manufacturing (Manual Fill/Finish), GMP Non-Sterile Manufacturing, and formulation
  • Consultants offer regulatory expertise to proficiently help you navigate through regulations and QA/QC-related projects

Your partner for OTC product testing. Let's find your solution.

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