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“Labeling and packaging issues are the cause of 33 percent of medication errors, including 30 percent of fatalities.”   
                                               
Institute of Medicine of the National Academies

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International Packaging and Labeling

International Labeling

International labeling and packaging poses many challenges. Stringent requirements for international labeling specify text dimensions, type sizes, graphic elements, symbols, and language for implantable devices, sterile devices, OTC products, diagnostic products, radiation emitting devices, contraceptive devices, and other medical and non-medical devices. Country-specific regulatory requirements further compound a complex issue.

Requirements for multi-language labels make efficient layout important and flexibility urgent.

enLabel gives you the ability to meet all international labeling regulations, gain marketplace acceptance, maintain your company's brand integrity and insure international user comprehension. We understand the unique requirements and challenges of international labeling.

Packaging and Labeling Challenges

  • Barcodes (EAN or country specific)
  • CE Marking
  • Country of Origin
  • Gray Market Sales & Security
  • Languages organized to language groups
  • Addendum labeling at point of distribution vs. Over-Labeling
  • Tied into original production & manufacturing for Lot/Expiration specific details
  • Rules driven destination language printed & applied to achieve zero defect
  • Gray markets thwarted by only printing language specific to destination
  • Country specific regulatory requirements guaranteed
  • Supplier compliance for distribution partners

enLabel Benefits

Full unicode capability

Ensure compliance to international standards

Maintain the integrity of your brand
Track and collaborate throughout your global enterprise
Respond to country-specific requirement changes immediately
Insure user comprehension & marketplace acceptance with multi-language capabilities

Compliance Expertise FDA 21 CFR Part 11, EU MDD, OSHA, DOT, GMP, and UDI

 

Branding and Labeling
FDA Part 11 and UDI
Track and Trace
Product Mix Avoidance
Pick Pack Ship
Supply Chain Distribution
Uniform Supplier Compliance
Electronic Device History Record
International labeling
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