top of page
Cytiva+hero+image.jpg

INN & USAN Development | Pharmaceutical brand naming  Regulatory name approval support

Readge is an independent European pharmaceutical naming consultancy, specialising in INN/USAN development, drug brand naming and EMA/FDA regulatory support.

dabd1cbe-43d3-478c-ad27-5a9d434f2efb.png
e2a36c3c-3c25-4ed8-98c5-14aa94cc10ac.png
38b63122-3a46-4d81-a5ab-374f2f21eb4f-1.png

​INN & USAN Development

Scientific nomenclature assessment, name creation, stem evaluation and submission support for WHO INN and AMA/USAN procedures.​​

Pharmaceutical Brand Naming

Strategic development of distinctive proprietary names, supported by trademark, linguistic and medication safety screening.​​

Regulatory Name Approval Support

Regulatory naming strategy, risk assessment and submission preparation for EMA, FDA and other relevant authorities.​​

Global reach, one name

As the world becomes more connected and markets converge, your ambition to operate globally requires an approved INN or USAN and a brand that works seamlessly across borders.

​​

You seek guidance to achieve your goals.

That's where we come in. We specialise in developing Non Proprietary and distinctive brand names, approved by the relevant authorities, ensuring compliance with regulatory standards in every market.​

Our experienced, strategic, and creative team works with you to navigate the complexities of global naming. We ensure your INN/USAN or brand name is unique, relevant, legally compliant, and ready for success in your intended markets.

Based in the Netherlands · Serving pharmaceutical and biotechnology companies worldwide

Scientific, strategic and regulatory expertise

​We combine scientific understanding, strategic creativity and regulatory expertise to develop distinctive pharmaceutical brand names and scientifically appropriate nonproprietary names. 

​

Our expertise covers international naming requirements and procedures involving the World Health Organization (WHO), the USAN Program, the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and national regulatory authorities like the UK's MHRA, Germany's BfArM and France's ANSM.

​

From initial name development and screening to regulatory submission preparation and authority feedback, we help pharmaceutical companies navigate complex naming procedures, anticipate potential objections and minimise regulatory risks.

More than creativity

Pharmaceutical naming requires more than creativity. A successful name must also meet the regulatory, scientific and medication safety requirements of the markets in which a medicinal product will be introduced.

 

By considering these requirements early in the naming process, Readge helps clients develop names that are not only distinctive and strategically relevant, but also better prepared for regulatory scrutiny across multiple markets.

 

Readge supports pharmaceutical and biotechnology companies in understanding and navigating naming requirements across international and national regulatory frameworks.

​

 

Our expertise includes:

​

  • WHO – World Health Organization: International Nonproprietary Names (INN), nomenclature assessment, stem selection and submission support.

  • USAN – United States Adopted Names: Nonproprietary name development, USAN application preparation and coordination with the WHO INN process.

  • EMA – European Medicines Agency: Proprietary name development, Name Review Group (NRG) requirements, screening and submission support.

  • FDA – US Food and Drug Administration: Proprietary name evaluation, medication error risk assessment, POCA considerations and submission support.

  • MHRA – Medicines and Healthcare products Regulatory Agency, United Kingdom: Proprietary name assessment and UK-specific naming requirements.

  • BfArM – Federal Institute for Drugs and Medical Devices, Germany: German regulatory naming requirements and national considerations.

  • ANSM – French National Agency for Medicines and Health Products Safety: French regulatory naming requirements and national considerations.

 

By considering these requirements early in the naming process, Readge helps clients develop names that are not only distinctive and strategically relevant, but also better prepared for regulatory scrutiny across multiple markets.

What naming questions do we deal with?

To make it clear what questions are presented to us and how we help clients with them, we created a persona, Dr Sophie de Vries, with all the naming-related elements that concern her.

Dr Sophie de Vries Regulatory Affairs professional

Meet Dr. Sophie de Vries

 

Age                 : 42
Role.               : RA Manager at a mid-sized pharmaceutical manufacturer
Education.      : Master’s and PhD in Pharmacy
Experience.    : 15+ years in RA, deep knowledge of EMA and FDA procedures
Company type: International pharma company focused on new drug development
Digital literacy: Highly skilled; uses digital tools daily​​​​

Sophie represents a growing group of highly experienced regulatory professionals who are committed to bringing safe and effective medicines to market efficiently—without naming setbacks. At Readge, we work closely with people like Sophie to ensure that the name approval process never becomes a bottleneck.​​

​​Key questions from Regulatory Affairs professional Sophie

​

  • Can Readge develop a clear brand strategy and a structured naming system for our portfolio

  • What is the full process for obtaining an approved INN and brand name?

  • What guidelines do the FDA, EMA, and WHO follow when evaluating names?

  • How does Readge help prevent rejection of our proposed (brand) names?

  • What are the most common reasons for name rejection?

  • Can Readge support us through WHO-INN, EMA, and FDA naming approval procedures?

  • How quickly can we expect results?

  • What experience does Readge have in submitting naming dossiers for pharmaceuticals?

  • What are the costs associated with Readge’s naming consultancy?

  • How does Readge manage communication with regulators and authorities?

  • Can Readge assess the risk profile of existing brand names?

 

Motivations that drive Sophie

​

  • Achieving full regulatory compliance without delay

  • Avoiding rejections by submitting thoroughly researched and well-justified name proposals

  • Partnering with a team that specializes in regulatory naming strategies

  • Reducing internal pressure and minimizing errors in complex naming processes

  • Ensuring a smooth and timely product launch

  • Protecting brand names from legal or commercial risks

  • Developing a brand strategy for our portfolio and pipe line developments to come

 

Frustrations and roadblocks we help Sophie eliminate

​

  • Rejections of submitted names by WHO, FDA, or EMA

  • Launch delays due to slow or failed name approvals

  • Lack of internal expertise in naming regulations and best practices

  • Unclear communication with global regulatory bodies

  • Mounting pressure from aggressive time-to-market deadlines

  • Limited capacity within the internal regulatory affairs team

​​

 

Sophie about Readge

​

The experienced specialists at Readge understand that naming is not just a creative challenge—it’s a regulatory one too. Their process is built  to align with the requirements of global authorities, ensuring that every name that is developed is compliant, distinctive, and approval-ready. Readge brings clarity, speed, and certainty to the naming process—so we can focus on bringing life-changing therapies to patients.

​

Want to learn more about our expert services? Contact us for a virtual coffee and your questions

Expert guidance, proven results

To further emphasize the specialism, Globrands' expert unit Pharmanaming, established in 2005, has become the independent consultancy Readge pharma naming with effect from 1 January 2025

​

The Readge pharma naming specialists deliver exactly what you need, guiding you to create the successfully approved INN or brand name you envision, offering services in brand strategy, clinical trial names, name development for drugs and devices, verbal branding, trademark searches, market research, safety checks, regulatory compliance, submission support for regulatory approval and visual identity.

We don’t rely on past successes but focus on continuous improvement. Our commitment to innovation, creativity, user appeal, and regulatory approval sets us apart. Our work can exceed even the best, like Brand Institute, through personal attention and expert guidance. 

                                 

We do things the right way, not settling for less. Our goal: 100% customer satisfaction, achieved through collaboration with specialized professionals, agencies, and pharmaceutical experts worldwide. And yes, also with the help of AI.

The Readge blog

Looking to navigate the complex world of drug naming with more confidence? The Readge pharma naming blog offers articles, comments and insights into everything involved in regulatory naming; from INN/USAN to brand name and company name creation and approval process.

​

You’ll find:

​

  • Practical tips for avoiding rejection by EMA, FDA and WHO

  • World wide examples of what works (and what doesn’t)

  • Strategies for building a naming system on all levels

  • Articles and perspectives from experts around the world

 

Whether you're naming your first product or managing an entire portfolio, our blog gives you useful and instructive information.

Recent blogposts 

Naming a drug : from creation to approval

The first step in naming a drug is finding its generic or non-proprietary name and have that approved by the WHO. The International Non-proprietary Name, also known as INN or generic name, is the official, standardized name given to a drug that identifies its active ingredient. It is not owned by any company and is used globally to ensure consistency and avoid confusion between different brands or versions of the same medication. For example, although OTC, "ibuprofen" is the non-proprietary name for the active ingredient found in many pain-relief products. One of the many 'Ibuprofen' brand names on the market is Advil​​​​​

ibuprofen.jpg
advil.jpeg

​​​​​Two organizations must approve the names of generic drugs: the United States Adopted Names (USAN) Council and the World Health Organization (WHO) INN Programme. This ensures that patients and healthcare professionals can safely communicate about medications, regardless of location.

 

Generic names follow a formula. The suffix, or "family name," provides important information about how the drug works in the body. For example, Viagra’s generic name is sildenafil. The suffix “afil” indicates its role as a PDE 5 inhibitor, which helps control blood flow. Other erectile dysfunction drugs, such as tadalafil (Cialis), vardenafil (Levitra), and avanafil (Stendra), also use the “afil” suffix.

 

The prefix is more creative, chosen to be distinct from other generic names and easy to pronounce.

There are several rules when creating these names:

​

  • The prefix must have two syllables to differentiate the drug and provide variety.

  • Certain letters (Y, H, K, J, and W) are avoided since they are not used in some languages with the Roman alphabet.

  • The name cannot include the company’s name or any promotional terms (like "best" or "strongest").

  • It must avoid medical terms that could limit the drug's use to a specific purpose, allowing for future broader applications.

 

Once 3 to 6 potential names are selected, they are submitted to the WHO. If accepted, the name is forwarded to USAN for review. If USAN approves it, the name is published on the proposed International Nonproprietary Names (INN) list. Over the next four months, the public can object. If no objections are raised, the name is added to the recommended INN list, and the drug can be referred to by its nonproprietary name instead of its code.

Want to learn more about our expert services? Contact us for a virtual coffee and your questions

The process of finding the right name

​​Unlike generic names, a brand name isn't tied to particular suffixes, which allows for more creativity.

The name is meant to be representative of the drug in some way, ranging from abstract ideas, tonality, strong sound or gentle sound. It can be imagery. You hear a word and it brings something positive to mind, or a nice association that isn’t a claim. Several rules apply to developing the brand name for medications. For starters, the name can’t make an overt claim about what it does, nor can it be promotional. It should avoid any use of generic name stems and everything should be done to avoid confusion.

​

 

The process roughly works like this

 

Readge's Pharmanaming team begins with establishing the brand's positioning, writes a brand story, determines the framework conditions with the client's regulatory department and a place and relation in the product portfolio, sets the schedule, who is involved, what submission procedure will be followed (FDA, EMA, DCP or CP), involves the different countries if necessary and investigates possible creative routes. When all that is done and there is a good picture of the goal we want to get to, potential lists of hundreds of names are created, and based on all kinds of checks and searches these lists will need to be dramatically reduced. In the end, The Food and Drug Administration (FDA) will review only one proposed name at a time, and the European Medicines Agency (EMA) will review only two.

​

The narrowing-down process begins with several checks and surveys for further elimination, that include:

 

  • Trademark legal screening and clearance in the relevant classes (mostly 5 and 10). A team of attorneys scrutinizes each name to make sure that name is truly unique. All companies developing drug brands have to be diligent that it’s not getting too close to other company's brand names, or generic names.

 

  • Checks in the INN (International Non-proprietary Names) published registers by the World Health Organisation

​

  • Pharma in Use checks in the WIPO register

​

  • POCA checks (FDA Phonetic and Orthographic Computer Analysis)

​

  • Domain name and social media availability checks, for defensive reasons. Far from all brands are registered, while there are names used online with which you do not want to be associated 

 

  • Linguistic checks. Does the drug name translate ok? The goal is to have a product that is appealing on a global scale, so it’s important to make sure it sounds and reads okay, regardless of the language or dialect. The brand name is checked in major world languages to make sure the name in its entirety does not mean or imply a word or phrase that would be inappropriate or embarrassing.

​

  • Safety checks for interpretation during the prescription process. Safety is the major focus in naming drugs. If one medication name is confused with another, the mistake could have serious consequences. To avoid any confusion, make sure that the proposed names do not look or sound like another that when coupled with an analysis of similar prescribing characteristics (dose strength, frequency, route of administration, etc.) could produce a medication dispensing error. A prescription simulation interpretation tests with verbal orders, computer entry orders, and handwriting to see if the name could be confused with another when written in a doctor’s potentially messy script. 

 

  • Perception checks among health care professionals, to gauge how they respond to the different names, inquiring about areas such as safety as well as general likeability of the way the word looks, sounds and how memorable it is.

​The final steps: submission and approval

​

All of those steps shorten the list to a final handful of just around three names. The project team then selects the favorite name to submit to the FDA and their favorite two names to submit to EMA. At long last, they wait to find out if the name is approved. While two to three years seems like a long time for a drug brand name to be developed, screened and ultimately accepted, it’s an important process that no other industry has and is designed with the patient in mind.

But those steps are absolutely needed to ensure that every medication name is as distinct as it can be. 

strategy

Strategy determines the mission and indicates what needs to be done to achieve the vision and the predetermined goal. Brand strategy defines the rules and guidelines on how, what, where, when, and to whom you communicate your consistent brand messages, leading to emotional connections.

  • Brand name and verbal branding audit

  • Brand and name positioning 

  • Brand architecture and name system

  • Brand concept development

  • Brand narrative and verbal branding

  • Brand to market strategy

22686c_ec9af57c66fa489ca4fc7572cc8d8c62~mv2.jpg
bottom of page