Product Labeling Strategy

Labeling that complies, informs, educates

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What to Know

A non-industry outsider may ask, “What’s in a label?” To which every drug developer responds, “Everything.” In addition to the carton messaging, product labeling regulations include many leaflets, inserts, and other statements to educate on the product.

The EU provides specific labeling templates that must be followed. The FDA has a website detailing its labeling requirements. Because in pharmaceuticals, “product labeling requirements” encompass far more than just a box with a product name. A regulatory affairs labeling expert ensures that your drug product labeling strategy and all components comply in your intended markets.

How We Can Help

I3 Infotek product labeling consultants are experienced in working with global regulators to create compliant prescription (and OTC) drug labeling portfolios. Our pharma compliance specialists can manage every aspect of labeling, including:

  • Draft complete labeling strategy for the drug
  • Submit NDA, BLA, ANDA filings
  • Perform carton and container planning
  • Complete multi-country template filings for all manner of applications
  • Create Prescribing Information (PI) (both PLR and non-PLR, non-PLR conversions)
  • Prepare all patient labeling content and formats (medication guides, use instructions, pt package inserts)
  • Comply with all 21 CFR physician labeling rules (such as 21 CFR 201.56-57)
  • Determine and prepare pregnancy and lactation literature requirements

Let us know what you need. We are on it.