Polish startup Regunaut is developing a platform based on large language models designed to automate drug registration processes and regulatory compliance tasks in the pharmaceutical industry. Founded by Małgorzata Łuksza and Katarzyna Rzewuska, the company is building what it describes as an agentic operating system for regulatory affairs teams. The company has announced that it has been accepted into PharmStars, a US accelerator focused on startups operating at the intersection of digital health and the pharmaceutical sector.
Regunaut is building a tool intended to streamline tasks that are still largely performed manually today. These include both launching new medicinal products on the market and maintaining regulatory approvals in individual countries after launch. In practice, this involves monitoring legislative changes, managing documentation, renewing licences and handling so-called variations, meaning changes to a product’s registration dossier. Many companies carry out such activities simultaneously across dozens of jurisdictions, which results in high costs and a significant risk of errors.
According to data presented by the company, maintaining a mid-sized regulatory affairs team can cost between €0.5 million and €1 million per year. The classification of more complex changes with the support of external consultants may cost more than €30,000. Time is another major issue. In the pharmaceutical industry, even minor delays in bringing a product to market can translate into measurable financial losses. Regunaut points out that each month of delay may mean the loss of between €2 million and €10 million in revenue, while some estimates put the cost of a single day of delay at hundreds of thousands of dollars.
The startup aims to address these challenges with a platform that combines different functions in one working environment. The tool is intended to support research, operational tasks and the creation of a knowledge base covering a company’s drug portfolio and internal procedures. Instead of relying on spreadsheets, email correspondence, fragmented databases and external consultants at the same time, users are meant to work within a single system.
A key component of the solution is a set of specialised AI agents, each responsible for a specific type of task. These include calculating registration fees, classifying documentation changes, verifying labelling or monitoring regulatory changes across multiple countries at the same time. According to the company, the platform not only performs tasks but also remembers the user’s working context and gradually develops a better understanding of the specific company and its product portfolio.
Regunaut stresses that its solution can be used both for simple, one-off tasks and for more complex strategic processes. One example is the preparation of a regulatory strategy for entry into a new market, which in the traditional model may take from eight to ten weeks. According to the startup, with the use of its platform such a process can be shortened to just a few minutes. The company also emphasises that the quality of the agents’ work is supervised by experienced regulatory affairs experts, which is intended to reduce the risk of errors in an area where precision is critical.
The company has also shared details of its market traction to date. Within a dozen or so months of launching the platform, Regunaut attracted users from more than 40 pharmaceutical companies operating in over 30 countries. According to figures provided by the startup, the system has performed more than 5,300 so-called agentic executions, and client teams have saved more than 10,000 working hours as a result. Contracted annual recurring revenue currently stands at €160,000. The startup is also in talks with large pharmaceutical companies in Poland and abroad.
The founders say they are operating in a market with strong growth potential. According to estimates cited by the company, the value of the global regulatory affairs market in pharmaceuticals alone reached around $10.1 billion in 2025. When the medical devices segment is included, that figure rises to $18.1 billion. Forecasts for 2033–2035 point to further growth to between $20.7 billion and $36 billion, with a compound annual growth rate of 7–9%.
Regunaut is led by people combining industry and technology experience. The role of CEO is held by Małgorzata Łuksza, previously associated with one of Poland’s leading biotechnology companies, with operational and regulatory experience as well as a Sorbonne doctorate. The company’s CPO is Katarzyna Rzewuska, who previously headed a regulatory department in the biotech sector. The team has also been joined by Jernej Čop as CTO, a technology executive with 15 years of experience in building digital platforms. Regunaut also employs Primož Jeras as Head of Engineering and Michał Suchocki as Head of Product. The scientific board is chaired by Professor Łucja Kowalewska of the University of Warsaw, a specialist in pharmaceutical law.
The company’s early development has been supported by AIP Seed. The fund has so far invested around $100,000 in Regunaut in an angel round. According to the company, the cooperation included not only funding, but also strategic support, help with team building and assistance in positioning the product on international markets.
An important element of Regunaut’s current stage of development is its acceptance into the PharmStars programme in Boston. This accelerator focuses on partnerships between startups and the pharmaceutical industry. Its regular participants and partners include global corporations such as Boehringer Ingelheim, Eli Lilly and Takeda. The main theme of the Spring 2026 cohort is “Digital Innovations in Operations and Outcomes”, which aligns closely with the profile of the Polish startup. The programme concludes with a presentation in front of representatives of the largest pharmaceutical companies, which for young businesses can be an important route to building commercial relationships and signing major B2B contracts.
According to information provided by Regunaut, 102 startups have so far passed through PharmStars and together they have raised more than $1 billion in funding. Participation in the programme itself is linked to a $100,000 investment. In the previous edition, the Polish company Infermedica took part, and Regunaut’s presence in the new cohort reflects the growing visibility of Polish firms developing technologies for the healthcare and pharmaceutical sectors.
Regunaut’s story stands out for several reasons. First, it illustrates the growing role of Polish startups in developing tools for the global pharmaceutical industry. Second, it concerns a field regarded as particularly demanding and conservative, where AI-based automation has developed more slowly than in many other market segments. Third, it fits into the broader trend of building specialist AI tools for specific industries and use cases rather than general-purpose solutions.
Regunaut says that the next stage of development will include expansion into new jurisdictions, the addition of new agents and the extension of the platform’s functions into further areas of pharmaceutical company operations. For now, however, the startup remains focused primarily on regulatory affairs, a field that for years has remained one of the most labour-intensive and costly operational areas in pharma.
