Regulatory


Regulatory Services

Brand or Proprietary Name Safety Research

Consults and Rebuttals

Failure Mode and Effects Analysis

Gap Analysis

Name Safety Reports / Submission

Nonproprietary (USAN / INN) Name Research

Product Labeling, Packaging and Trade Dress Research

Promotional / Advertising Research

Regulatory / Safety Review of Container and Carton Labels and Packaging

Risk Management Plans

Submission Strategy

USAN / INN / STEM / CLASS Name Development

The Drug Safety Institute (DSI), a subsidiary of Brand Institute, was founded in 2004. DSI is dedicated to improving the safe use of Pharmaceuticals by providing a global, state-of-the-art, research model for proprietary (brand and line extension) and nonproprietary (USAN/INN) nomenclature research. In addition, DSI offers a medication error prevention analysis associated with labeling of pharmaceuticals, biological products and medical devices. DSI also offers various risk management strategies to our clients.

 


At DSI our plan is to make the Brand Institute methodology for proprietary and nonproprietary name safety testing reflective of the FDA and other regulatory agencies? review processes.

 

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