OTC Laboratory Product Testing Services

Certified Laboratories is an industry leader in Over-the-Counter (OTC) testing throughout the product lifecycle. We confirm active and inactive raw material, in-process and finished goods specifications of identity, purity, strength and quality using validated and verified testing methods and equipment.  

Serving both OTC manufacturers and distributors, we are committed to helping you ensure your product’s quality. We can assess the of presence of microbial contamination, establish shelf-life, and inform product labeling.   

Why Do Over-the-Counter (OTC) Testing with Certified Laboratories?

FDA requirements for OTC product testing is defined in OTC Monographs and in FDA’s current Good Manufacturing Practices (cGMP) regulations: 


21 CFR 210 for Manufacturing, Processing, Packing, or Holding of Drugs


21 CFR 211 for Finished Pharmaceuticals

Compliance with OTC Monographs and cGMPs help ensure product quality, efficacy, and reliability.

Certified Laboratories are experts in FDA Monograph and cGMP testing and regulatory requirements. Our full scope of laboratory capabilities includes chemistry, microbiology, toxicology, in-package stability and shelf-life, sterility, and quantitative components to inform product labeling for both APIs and excipients. We are an ISO accredited laboratory, helping you to ensure product quality with our state-of-the-art equipment and validated/verified methods 

Regardless of your dosage form or packaging form, Certified Laboratories is your laboratory expert for OTC product testing needs. 


Chemistry Testing

  • OTC-Specific Monograph 
  • Raw Materials, In-process, and Finished OTC Products 
  • Active Ingredients 
  • Excipients 
  • Dissolution and Disintegration  
  • Sterility Studies 
  • Identification and Quantification of Elemental Impurities  
  • Residual Solvents 
  • Viscosity 
  • Moisture 
  • GMOs 
  • Mycotoxins 
  • Heavy Metals 
  • Allergens 
  • Pesticides & PCBs 
  • Adulterants 


  • Preservative Efficacy

Microbiology Testing

  • Microbial/Pathogen Contamination 
  • Preservatives 
  • Challenge Studies 
  • Probiotics 
  • Microbial Enumeration

Stability and Shelf-Life

  • Degradation 
  • Accelerated 
  • Photostability


  • Flavorings 
  • Colors 
  • Textures 
  • Odors

Certifications & Accreditations

Certified Laboratories is a fully compliant cGMP/GLP testing facility following the 21 CFR 111 sub J and ISO 17025 standards.

Burbank, CA

Formerly Micro Quality Labs

Carrollton, TX

Formerly Microconsult

Certified Laboratories Testing Certification

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