They Will Launch Their First Two Drugs on the European Market by the End of the Year

Health is a global matter. It knows no borders, neither national nor continental. The whole world is seeking and exploring solutions for diseases. Everyone wants and must have the right to the highest quality therapy at a normal price. That is why we view health and solutions as a global story and set up our business and company accordingly,” emphasizes Goran Rešić, co-founder of PGF Pharma International, which helps pharmaceutical manufacturers outside the European Union to align their products with European requirements, register them, test them, and bring them to market. PGF Pharma International thus enables its distribution partners commercial access to European markets through its integrated one-stop shop model as a place connecting functions that clients often have to negotiate with multiple different providers. This shortens communication and operational pathways, Rešić emphasized, reduces the chances of error, and allows for better control of the entire process from documentation to commercialization.

Connecting the World and the EU

Today, PGF Pharma International covers almost the entire path of a drug to the EU market: consulting and preparation for inspections under the EU Good Manufacturing Practice (EU Good Manufacturing Practice, EU-GMP), regulatory strategies and drug registration, preparation and alignment of CTD/eCTD (Common Technical Document/electronic Common Technical Document) documentation, and pharmacovigilance with the QPPV function (Qualified Person Responsible for Pharmacovigilance). They are also involved in import and storage, laboratory testing and quality control, QP batch release (Qualified Person – a qualified person who releases the drug to the market), serialization, distribution, market access, and commercialization, with licenses for good distribution practice and the production and import of drugs issued by the Agency for Medicinal Products and Medical Devices, HALMED. However, in addition to services, the company is also developing its own commercial portfolio, and Rešić announces that by the end of the year, they will launch their first two drugs on the European market, Enoxaparin and Rivaroxaban. Enoxaparin is a low molecular weight heparin in injection form for the prevention and treatment of blood clots, he explains, while Rivaroxaban is an oral anticoagulant for the prevention and treatment of blood clots and reducing the risk of stroke.

– Our goal was to build a reliable regulatory and operational platform from Croatia that enables partners a safer and faster path to European patients. Croatia provides us with a quality base within the EU regulatory framework, and our market has been international from the start. As much as 99 percent of our revenue in 2025 will come from outside Croatia. We work with clients and partners from Europe, the United States, and Asia, with India, China, Turkey, South Korea, Taiwan, and Vietnam particularly highlighted in strategic materials. We will soon start interesting projects in the Middle East – Rešić expects, directing further expansion towards EU markets by developing a distribution network.

It Can Be Done from Croatia

The model also intends to be enhanced by expanding EU-GMP laboratory capacities, introducing new validated analytical methods and equipment, and further digitizing validated systems. The goal, he emphasized, is for the client to manage an increasing number of projects and markets through one platform while maintaining the same standards of quality and regulatory compliance. He plans to include new artificial intelligence programs in the business, with the largest portion of capital going towards increasing capacity, expanding the portfolio, and creating recurring revenue from their own drugs.

– In the next three to five years, we want to be a fully integrated pharmaceutical company with a presence in markets across Europe. We compete with multinational companies through integration, speed, and specialized knowledge. Speed and expertise are our comparative advantages. PGF shows that an international pharmaceutical company can be built from Croatia that connects European knowledge, regulatory standards, and global manufacturers. Our growth is not just a commercial story because by better connecting supply chains, manufacturers, and European markets, we contribute to a safer supply and availability of therapies for patients – explained Rešić.

Bonds for Capital

On the path of development, Rešić is also raising capital by issuing bonds, and in March, the Zagreb company offered its bonds to raise one million euros. Of that, 150 thousand euros will be spent on expanding laboratory and EU-GMP capacities, 350 thousand for regulatory fees and legal support in bringing drugs to market, and 500 thousand in the development and creation of their own portfolio and distribution network. The minimum investment was 1,000 euros with an interest rate of 6.5 percent and a maturity of two years.

– Bonds are a rational instrument for a company that is already operational, has stable revenues, and wants to accelerate growth. They have allowed us to raise capital without diluting ownership and bringing in new co-owners while retaining full control over the direction of development. Diversification of funding sources and flexibility were also important to us. Pharmaceutical projects require large initial investments in laboratories, regulatory processes, and product portfolios, so it is not wise to rely solely on banks or our own money. We financed the scaling of a model that has already been operationally validated and generates revenue. The issuance is also the first step towards a long-term relationship with the capital market and a broader community of investors. Banks in Europe are still very conservative and do not have programs and tools to assess complex entrepreneurial projects, so we use various sources – explains Rešić.

Gradual Development

Rešić and Marko Morić founded PGF (Pharmaceutical Global Future) Pharma International in 2020 after providing consulting for good manufacturing practices in the EU to Asian pharmaceutical manufacturers in Vietnam. It quickly became clear to both that manufacturers need more than just advice to enter the EU market; they need a partner who can connect regulatory requirements, quality, laboratory testing, import, marketing authorization, and commercialization.

– From the initial consulting model, we evolved into an integrated pharmaceutical platform based in Croatia. In international business, we have become a company that serves as a bridge between Europe and the world in both directions. The initial invested funds were ours, but from the first signed contract in 2020, all the funds we earned were reinvested into further development and business expansion. In the first year of operation, we did not pay ourselves any salaries as owners. We gradually developed the business, reinvesting the profits earned and using short-term loans to maintain liquidity. The last round of financing was the issuance of our first corporate bond. In Croatia, we are otherwise limited by a small domestic market, the slowness of some administrative processes, demanding paperwork, limited availability of highly specialized pharmaceutical experts, and difficult access to development capital for smaller companies. Croatia provides us with the EU regulatory framework and quality people, but growth must come from international markets – Rešić is clear.

Revenue and Profit Growth

Although the required expertise is very specific and niche, the number of employees has grown significantly with the business, increasing from eight in 2024 to 25 by the end of this year. So far, Rešić has focused on strengthening the regulatory affairs department, laboratory, and quality department, as they are key in the European pharmaceutical system. However, since very specific experience and responsibility are required, he develops experts internally and connects the permanent team with proven external collaborators.

PGF has also established its EU-GMP analytical laboratory within BioCentra, which can perform thousands of analyses per year at full capacity. Further expansion of laboratory and EU-GMP capacities will follow the increase in the volume of analyses and batch release services and the introduction of new methods and equipment.

The company’s development is also reflected in revenues, which amounted to 3.43 million euros last year, an increase of 318.18 percent compared to 2024, and net profit, which grew by 83.52 percent, reaching 239,655 euros. According to Rešić, revenue growth is largely the result of expanding international regulatory and consulting projects, increasing the number of clients, and developing additional services, including laboratory testing and EU-GMP support.

– Cycles in the pharmaceutical industry are extremely long until all regulatory requirements are met, so the results of some initiated processes and investments come with a time lag. Profit growth is a consequence of a larger volume of business, better utilization of infrastructure, and the expert team we have built over the past years. Revenues have grown faster than fixed costs, even though we have continued to invest heavily in the laboratory, quality department, regulatory affairs, and portfolio development. The loss in 2023 of 132,600 euros was related to the company’s development phase, during which we invested in people, licenses and permits, validated software systems, regulatory capacities, and the preparation of laboratory and quality infrastructure before these capacities could generate full revenue. It was not a loss of market, but an investment in the platform for the next phase. The growth of international projects and the gradual activation of built capacities returned the business to profitability in the next period – notes Rešić.

This year, growth continues, but the true results of investments this year will, in Rešić’s opinion, be visible in 2027 and the following years. However, inflation and rising costs affect the prices of equipment, laboratory materials, logistics, and labor, although direct exposure to Croatian economic trends is limited as most of PGF Pharma’s revenue is generated abroad. Wars and geopolitical tensions affect supply chains, and they depend on the availability of active pharmaceutical ingredients, transport, delivery times, and the risk of the other contracting party. To these challenges, Rešić responds by diversifying suppliers, partners, markets, and sources of income, as well as regular cash flow planning.

There Will Be Drug Shortages

– In today’s pharmaceuticals, supply security has become as important as price. Unfortunately, the prices of some generic drugs are so low in the EU that we will soon witness significant shortages and disruptions in supply chains. Prices have not kept pace with rising costs and inflation, and we are approaching a point where corrections or shortages will occur. We see all these challenges as an opportunity for our company, although long, complex, and changing regulatory processes pose an obstacle. Delays in validation, inspections, or registration can postpone an entire commercial project – emphasizes Rešić.

He notes that due to pressure on healthcare system costs and the expiration of patents (off-patent), generic and off-patent drugs are rising in the market, along with regulatory complexities and demand for reliable EU-GMP partners. The right partners can cover and shorten the path of products to market without compromising quality.

– Europe is dependent on Asia for active pharmaceutical ingredients and some finished drugs, and supply chains are interconnected worldwide. After the corona crisis and geopolitical disruptions, the lowest price is no longer the only crucial factor, but also supplier diversification, delivery reliability, and system resilience. At the same time, more and more new molecules and technologies are coming from China, India, so the US and Europe no longer have a monopoly on pharmaceutical innovation – observes Rešić.