ACMA Approve™

Enhance Approval. Prevent Errors.

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ACMA Approve offers a wide range of risk assessment tools that the industry can implement to enhance regulatory approval while promoting safe use of their products. Services include pharma trademark safety testing and product label review that incorporate proven evaluation methods.

We Can Help

Obtain regulatory approval of your drug trademark
“Error proof” your package label and labeling
Identify and mitigate risks during the drug development process and throughout a product’s lifecycle
Contest a name rejection
Engage with experts in medication safety and error prevention
Educate your team about Medication Error Prevention
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Customized Services

Global Naming
  • Safety and regulatory screening during name creation
  • Trademark safety testing using practitioner input and FMEA (failure mode and effects analysis) with report suitable for submission to applicable regulatory bodies including
    • US FDA
    • EMA
    • Health Canada
    • ANVISA (Brazil)
  • Scripting studies
  • Use of POCA (phonetic and orthographic computerized analysis) and analysis of results
  • Overcoming name rejections from a regulatory body
  • Nonproprietary name and biologic suffix review (USAN/INN)
Consulting
  • Risk assessments and risk mitigation strategies for
    • new products
    • changes in product presentation
    • dosage form
    • and more
  • Name creation strategy and risk assessment for
    • combination products
    • line extensions
    • additional indications
    • OTC switches
  • Error report analysis
  • Medication safety education
  • Risk assessments in preparation for Human Factors testing
Labels and Labeling
  • Review labels for compliance
    • FDA
    • USP
    • Code of Federal Regulations (CFR)
  • Package insert / leaflet review
  • Ensure label is not prone to
    • misinterpretation
    • errors
  • Partner with label designers to create clear and safe labels

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