As part of our new series, Leading The Way, we are proud to bring you exclusive insights from the leaders who are shaping the future of Zdravlje. In each interview, we’ll dive into their unique perspectives, key experiences, and the strategies they employ to drive our company forward. Through these conversations, we aim to highlight the vision, innovation, and leadership that have defined Zdravlje for decades.

In this first interview, we sit down with Dusan Cvetanovic, Senior Site Director, to explore his journey and his thoughts on the future of our industry.

1. In celebrating 70 years, what are some key moments or personal experiences that you believe have been pivotal in shaping our company’s legacy?

One of the key moments in shaping our company’s legacy was the total reconstruction of the OSD and other relevant facilities, utilities and the systems, and of course, the intensive development and continuous training of the employees, all in line with current requirements and guidelines from 2005 to 2008. This huge transformational project enabled us to meet the cGMP standards, leading to our EU GMP certification and entry into the EU market. It also marked the beginning of our CDMO journey, with the first product transfers to our site. Today we proudly serve approximately 40 markets around the world including the EU, UK, Australia, Canada, ex-Yugoslavia, South Africa, Middle East and Latin America.

2. How do you ensure that the factory’s operations are in sync with the company’s overarching strategic goals?

Transitioning from a large corporation to an independent company like Zdravlje is quite a challenging process. With this transition come new requirements and changes in business operations that shape our company’s strategic path. Our primary strategic goal is to ensure and grow our volumes by introducing new clients and products. While the path to achieving this is intricate, effective communication within the management and operational teams is crucial. It helps in setting clear expectations, understanding individual contributions, and aligning everyone with our common goals.

3. What current initiatives are in place to enhance operational efficiency and productivity within the factory?

The main initiatives are focused on optimizing and improving all current processes. This initiative is particularly important during the transition period until the target quantities are established and increased. To this end, we encourage all employees to propose improvements in the processes they are involved in, which could lead to significant enhancements and optimizations at all levels, while still preserving the core processes and GxP values.

4. Can you discuss any recent technological advancements or innovations that have been integrated into our manufacturing processes?

Technological advancement and innovation are critical factors that drive a company’s competitiveness and set it apart from others in the industry. Without a commitment to investing in cutting-edge technologies and equipment, maintaining a leading position can be challenging. Our company prioritizes innovation and consistently integrates new technologies into our products. Recently, we introduced a text-printing process on tablets and acquired advanced machinery for this purpose. We are also in the process of installing a new Roller Compactor for dry granulation and material preparation in tablet manufacturing. This method is particularly advantageous for products where water-based granulation is unsuitable, and we already have contracts for products that require this technology.

5. How do you uphold high standards of quality and compliance in our manufacturing operations?

By continuously monitoring current GxP requirements, implementing them through procedures and documentation, and providing ongoing training, we maintain compliance with GxP standards at the highest level. We demonstrate this through regular internal audits and activities aimed at improving our Quality Management System, which is further validated by GMP certifications from regulatory bodies. This fall, we will undergo a routine EU GMP inspection conducted by the Maltese regulatory agency. This inspection will renew our certification, which is recognized not only by the EU but also by regulatory bodies in many other countries. Through thorough preparation, internal audits, and continuous improvement of our Quality Management System, we will ensure recertification and the continued production of products for international markets.

6. What distinguishes our CDMO services from those offered by competitors?

The knowledge and experience of our employees, the quality of the products we manufacture, our readiness to collaborate and take responsibility, and our flexibility in negotiations and setting priorities are key strengths. As I mentioned earlier, the introduction of innovations and specific technologies allows us to meet the unique demands of our clients, which I see as an additional advantage compared to others in the industry. Working “hand-in-glove” with clients is central to our partnership philosophy. This helps us understand their short to long-term goals and therefore better serve them.

7. Could you share any recent successes or case studies from our CDMO business that showcase our strengths?

In collaboration with one of our clients, we have launched a unique extended-release form of Pregabalin tablets, significantly simplifying the administration of the medication and reducing the need for frequent dosing. Its launch in the EU market, along with its potential in other markets, has made a strong impact and strengthened our partnership with this client. This success has also attracted interest from other clients, and we have already received several inquiries and requests to initiate new collaborations.

8. How do you encourage a culture of continuous improvement and innovation within your team?

The culture of continuous improvement has long been present in our company and among our employees. Through various programs, we encourage employees to propose enhancements, and through constant communication and discussions with staff at all levels, we highlight the benefits that process improvements bring. As a CDMO company, each new product transfer opens up new opportunities to improve procedures, activities, and equipment. By thoroughly reviewing production and laboratory processes, we can analyze all activities and optimize every step, ultimately leading to increased efficiency in commercial manufacturing.

9. What emerging trends in the pharmaceutical manufacturing industry do you believe could impact our business?

Biopharmaceuticals and biosimilars are rapidly growing fields with an increasing presence in the pharmaceutical industry. We view our company as one that aims to incorporate these systems and products into our portfolio. Investing in this area is significant, but from a strategic perspective, it is essential for us to engage with these trends and contribute to their development.

10. What are the next steps for expanding our CDMO business?

We are constantly working on increasing production volumes and capacities, as well as expanding our cooperation with existing and new clients. Modern products are becoming more complex and many of them require special processing stages, which we are becoming familiar with. Given high client demand, we have already initiated a project to expand our coating capabilities, and the installation of new equipment is underway. We are closely monitoring the growth in demand and production volumes, analyzing the need for further investments—whether in manufacturing and packaging equipment or in laboratory capacities and specific requirements.