The pharmaceutical industry’s most trusted naming partner

FDA · USAN · NDA / BLA · Proprietary naming

The pharmaceutical industry’s
trusted naming partner

For over 30 years, Brand Institute has partnered on more FDA brand (proprietary) name approvals than any other agency in the world. Our team of regulatory experts, through our wholly-owned subsidiary, Drug Safety Institute, include former FDA naming officials who co-authored the agency's name review guidelines and guidance documents. We hold a 75% share of market for FDA Rx name approvals annually..

Former FDA naming officials USAN/INN strategy Proprietary name development LASA safety screening NDA / BLA submissions FMEA analysis
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    Brand Institute's regulatory subsidiary, Drug Safety Institute (DSI), is staffed by former FDA naming officials who co-authored the FDA proprietary name review guidance — the same documents your submission is evaluated against.
    CREDENTIALS
    Former FDA naming officials
    Co-authored FDA name review guidelines
    75% FDA Rx name approval share
    6,000+ names developed
    1,700+ INN/USAN names
    FDA submission expertise

    Every regulatory naming pathway, covered

    Whether you're filing an NDA, BLA, or OTC application with the FDA — or developing a USAN nonproprietary name for submission to the American Medical Association (AMA) — our regulatory experts help navigate the full naming lifecycle.

    💊
    NDA / BLA
    Proprietary name development
    FDA-compliant proprietary (brand) name development, LASA safety analysis, medication error risk assessment, and full submission dossier — prepared by former FDA officials.
    🔬
    USAN / INN
    Nonproprietary naming strategy
    USAN application strategy, INN alignment, stem selection, and AMA Council advisory guidance. The most complex naming step — handled by the team that helped write the rules.
    🏪
    OTC branding
    Over-the-counter brand naming
    OTC brand name development with FDA OTC monograph compliance. Consumer research, retail shelf impact testing, and LASA review for consumer medication safety.
    🧬
    Biologics
    Biosimilar & biologic naming
    4-letter suffix strategy for FDA biologic naming, interchangeability designations, and 351(a)/(k) pathway naming — including biologic LASA analysis.
    🩺
    Medical devices
    Medical device naming
    510(k) and PMA device name development. FDA device naming conventions, trademark clearance via USPTO, and brand strategy for Class I / II / III devices.
    ⚗️
    Clinical trials
    IND-stage trial naming
    Protocol-stage naming protects your commercial launch. IND application naming strategy that sets up a smooth NDA/BLA proprietary name submission later.
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    USAN / INN expertise

    The USAN advantage no other agency offers

    Former AMA naming leaders. Former WHO naming advisors.

    USAN (United States Adopted Name) selection is one of the most complex and consequential steps in drug development — and one that most naming agencies get wrong. Brand Institute's Drug Safety Institute includes former leaders from naming divisions at the AMA and WHO, alongside former FDA, EMA, and Health Canada officials — the same regulatory community that shapes the global nonproprietary naming system.

    • ✓USAN application filing and negotiation with the AMA Council
    • ✓INN submission to WHO — internationally harmonized naming
    • ✓Stem strategy (selecting the right pharmacological suffix)
    • ✓USAN/INN safety analysis — preventing confusion with existing names
    • ✓Class name and modifier strategy for drug families
    • ✓Nonproprietary name development for novel drug classes

    We name drugs across every therapeutic area and FDA submission type — from first-in-class biologics to OTC reformulations.

    Oncology
    mAbs, ADCs, small molecules, CAR-T, checkpoint inhibitors, radiopharmaceuticals, and more
    Biologics
    Biologic brands, biosimilars, reference biologics, 4-letter suffixes
    Rare / Orphan
    Orphan drug designation naming, rare pediatric disease, ultra-rare disorders, enzyme replacement therapies, specialty biologics
    Vaccines
    Prophylactic and therapeutic vaccines, mRNA vaccines, viral vector vaccines, pediatric vaccines
    CNS / Neurology
    Psychiatric, neurological, Alzheimer’s, anti-depressants, neurodegenerative disorders, epilepsy, and more
    Cardiovascular
    Heart failure, hypertension, anticoagulants, lipid management, arrhythmias, antiplatelet therapies
    Cellular & Gene Therapies
    CAR-T, TCR therapies, stem cell therapies, viral vector therapies, ex vivo and in vivo gene therapies
    Gastrointestinal
    IBD therapies, ulcerative colitis, Crohn’s disease, hepatology, gastroesophageal disorders, digestive health
    Immunology
    Autoimmune diseases, inflammatory disorders, immunomodulators, rheumatology, dermatology biologics, cytokine inhibitors
    Infectious Disease
    Antivirals, antibiotics, antifungals, HIV therapies, hepatitis treatments, anti-infective biologics
    Obesity & Weight Loss
    GLP-1 therapies, metabolic disease, diabetes-related obesity treatments, combination therapies, appetite regulation
    Respiratory
    Asthma, COPD, pulmonary hypertension, respiratory biologics, inhaled therapies, allergy and eosinophilic disorders
    Schedule free FDA consultation
    Full service menu

    Everything your US launch needs

    From naming strategy through FDA submission — one partner, every discipline, no hidden fees.

    01
    Name development
    Hand-crafted brand names built for FDA safety standards and US market resonance — creative team plus innovative AI-assisted generation.
    02
    FDA regulatory strategy
    Former FDA naming officials guide your submission dossier, rebuttal strategy, and FDA dialogue — maximizing first-pass approval probability.
    03
    LASA / FMEA safety
    Failure Mode & Effects Analysis (FMEA) per FDA guidance. Look-Alike Sound-Alike screening against all US-marketed drug names.
    04
    US trademark clearance
    In-house trademark attorneys conduct USPTO screening, federal and state database searches — no outsourcing, full confidentiality.
    05
    Market research
    US HCP and patient studies, name recall testing, and commercial viability assessment — benchmarked to historical US norms.
    06
    Visual identity
    Logo, labeling, packaging design — FDA-compliant layout with an award-winning design team. One agency from name to shelf.
    View our Solutions

    5,000+
    pharmaceutical names developed
    75%
    share of FDA Rx name approvals (2025)
    1,700+
    INN/USAN names
    30+
    years FDA naming expertise
    Client experience

    What US pharma teams say

    ""Thank You! What your legal prescreening Team did was beyond impressive.""
    Pfizer - Manager, Trademark Department
    ""Thank you, Brand Institute, for the great work and wonderful extra efforts. We greatly appreciate your willingness to go the extra mile.""
    Foresee Pharmaceuticals - CEO/CBO

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    Ready to name your next FDA submission?

    Free 30-minute consultation with a former FDA naming official. NDA, BLA, USAN, OTC — we cover every pathway.