Over-The-Counter (OTC) Product Testing Services

Everything you need to bring your product to market sooner.

Helping you bring your product to market sooner.

The Eurofins 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

Eurofins 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

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

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

Work with the experts at The National Food Lab, a Eurofins Scientific company, 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

Contact us:

Instrumentation

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

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

We are science at your service.

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 in OTC product testing. Let's find your solution.