Hand Sanitizer Production Fast Track to FDA Registration!

You make the product

We'll get your products & manufacturers FDA-qualified immediately!

Meet the consumer demand caused by the COVID-19 Pandemic!

FDA will now allow qualified drug manufacturers to compound hand sanitizers to the standards set forth by the FDA.

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Regulatory Services

Product Registration & Regulations Made Easy

ICRS Regulatory provides expertise in regulatory compliance needs across a number of industries producing and manufacturing Over The Counter (OTC) products.  It is important to note that many OTCs are classified as drugs which must meet the stringent regulations of the country in which they are sold.  In the United States, the FDA (Food and Drug Administration*) classifies many of these OTC products, including hand sanitizers, toothpaste, sunscreens, deodorant and shampoo, as drugs. Therefore, they are treated in the same manner as a prescription drug and must be registered and licensed as such. We help manufacturers, distributors and marketers worldwide in the areas of Regulatory Affairs, International Product Representation, Product Registration and International Labeling Compliance.  With offices in the United States (Los Angeles), United Kingdom (London) and the European Union (Dublin, Ireland), we have global expertise and reach!

*The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

Federal Food and Drug Administration manufacturing requirements for compliance of Over-the-Counter (OTC) Drugs in the US.

  • You must have a Drug Manufacturing License with US FDA
  • Product registration is also required, and there are other manufacturing and handling requirements.
  • You will need to follow Drug GMPs.

We can help quickly and efficiently fulfill these FDA regulatory requirements, often in less than a week!

  • We will provide you with the support needed to get your products to market!  
  • We have 27 years of experience in working with FDA and their mandates and can help you rapidly fulfill these requirements.

This is a timely issue and using the FDA temporary guidance will be a challenge, so please let us help you!

We Serve the Following Sectors
Retail (mass market) | Direct selling (multi-level marketing) | Infomercial/Script | Professional/Salon Boutique Specialty | Web Only Marketers | Contract/third party manufacturers

New Rules for Surviving the COVID-19 Pandemic

Thank you to James Robb, MD FCAP for allowing us to share this valuable information
The only way for the virus to infect you is through your nose or mouth via your hands or an infected cough or sneeze onto or into your nose or mouth.

  • No handshaking!  Use fist bump, slight bow, elbow bump, etc.
  • Do not touch your face, rub your eyes or mouth!  We touch our nose/mouth on average 90 times a day without knowing it!
  • Wash your hands thoroughly with soap for at least 20 seconds,                          
  • Use a greater than 60% alcohol-based hand sanitizer whenever you return home from ANY activity that involves locations where other people have been.
  • Keep a bottle of sanitizer available at each of your home's entrances and in your car for use after getting gas or touching other contaminated objects when you can't immediately wash your hands.

Read the entire article…