Regulatory

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.

Brand Institute embraces the goal of regulatory agencies in protecting the public health by ensuring the safety, efficacy, and security of brand names for human and veterinary drugs, biological products, and medical devices.

Cristina Milesi
Vice President, Safety 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.

Services Include:

USAN/INN/Stem Naming – Provide strategy on stem direction and options through appropriate INN and USAN nomenclature precedents/competitive compound analysis/mechanistic activity for a product in clinical development to obtain a worldwide nonproprietary name.

Nonproprietary (USAN/INN) Name Research – Input on sound-alike/look-alike potential for confusion, fit to therapeutic classification, and distinctiveness are obtained from a specific target audience in order to reduce the risk of prescription misinterpretation or confusion in the medication use process.

Class Naming – Development of a class name communicates the key attributes of the new category, is scientifically credible, and uses terms understood by both professional and consumer audiences.

Name Safety Research – Global safety research to ensure name development is in compliance with worldwide regulatory guidance. Name safety research helps sponsors of human drugs and veterinary drugs ensure proprietary drug names do not cause or contribute to medication errors or otherwise contribute to the misbranding of the drug.

Biologic Nonproprietary Name Suffix Research – Safety research to help ensure suffixes for proper names of biological products licensed under section 351(a) or 351(k) of the Public Health Service Act (PHS Act) submitted to FDA are in compliance with FDA guidance.

Regulatory Strategy – Provide regulatory guidance on product nomenclature strategies for Rx, OTC, veterinary, and device products, and provide strategic options that help formulate a plan for a successful, quick and efficient product launch to market.

Rebuttals – Prepare documents providing rationale and support for the use of a proprietary name that has been rejected by a health authority (e.g., FDA, EMA, HC). Former regulators also provide guidance and expertise in developing a strategic response to the health authority.

Failure Mode And Effects Analysis (FMEA) consultation – Provide a prospective risk assessment of a nomenclature strategy or proposed product design using an analytical approach that considers the medication use process while incorporating the end user’s needs, environments of use, design and commercial aspects. The systematic method can define, identify, and eliminate known and/or potential failures, problems, and errors before they occur or demonstrate support of the proposed nomenclature strategy or design. Each FMEA is tailored to the product being developed and the perceived risk.

Name Safety Reports – A DSI Name Safety Report is prepared for a single recommended name candidate and customized for the specific regulatory agency submission. The report includes an overall risk assessment of the proposed name where the data is derived from the DSI name safety research. In addition, the Name Safety Report is written to reflect information required by country specific guidance and name safety regulations. DSI also provides a draft cover letter document requesting review of the proposed proprietary name to be included with the FDA and Health Canada regulatory report submission.

Trade Dress Research – Review a proposed product within a pharmacologic class and compare the design features to currently marketed products. Includes information on design features of marketed products within the specified class including dosage form (capsule or tablet), color, imprint, size of capsule/tablet and packaging configuration. Provide written analysis of the most commonly used colors, sizes, dosage forms within the class and provide recommendations for product development to minimize error or provide adequate differentiation among the marketed class of products.

Regulatory/Safety Review of Product Labeling, Packaging – Review product labeling and packaging to minimize or eliminate hazards that can contribute to medication errors.