ACMA Approve™

Enhance Approval. Prevent Errors.

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

Medication Safety Experts

The ACMA Approve experts work with trademark, regulatory, commercial, branding and drug development professionals to help navigate the complex process of product approval by regulatory agencies.

ACMA Approve Featured Expert:

Nancy Globus, PharmD

Nancy is an industry-recognized and trusted expert and is committed to providing customized solutions in a personalized, effective and cost-efficient manner.

Nancy has decades of experience in risk mitigation and clinical practice which enable her to address medication safety and regulatory issues from the simple to the most complex. She honed her skills in medication safety during her tenure at the Med-ERRS subsidiary of the Institute for Safe Medication Practices (ISMP).

Nancy’s Specialties Include: medication error prevention, medication safety, trademark safety testing, regulatory assessment, package and label assessment for safety and clarity, failure mode and effects analysis (FMEA), risk assessment, FDA, EMA, Health Canada.

Nancy Globus Profile Image

Medication Safety Overview

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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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