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Pharmaceuticals – is a highly intellectual business, in which there is no place for thoughtless and spontaneous decisions


22.04.2020 (№ LDaily #3)

Pharmaceuticals – is a highly intellectual business, in which there is no place for thoughtless and spontaneous decisions

Managing partner of the group of companies Cratiya LLC Maxim Bagreev about the modern ways of pharmaceutical development in the country

The procedure of medicinal product state registration is much more complicated than it may seem. Dozens of highly qualified workers from the Ukrainian side work on preparation of the documentation and accompanying the state examination process: registration specialists, lawyers, clinicians, chemists, technologists, quality specialists, pharmaceutical security specialists, graphic designers and pagemakers. Coordination and strategic management of the company “Cratiya”, the largest consulting company for registration of medical products in Ukraine and CIS countries, are carried out by its founder and managing partner Maxim Bagreev.

: Maxim, tell us about the company “Cratiya”.  When was it created? What does it specialize in?

M. Bagreev: I founded this company 11 years ago. From the introductory courses of the institute, I combined studies and work, devoting a lot of time to my professional development. So when I was 24 years old, I have already had considerable experience in business, including two years of experience in medical products registration. But a key point to my success was a team of professionals, who believed in me in those first the hardest years of the company. They are the best specialists, stars of the Ukrainian regulations, who are the top managers in “Cratiya”. The teamwork of “Cratiya” exclusively leads to success. I am also very grateful to my mom for the help and support.

Now are team consists of more than 120 people, a quarter of who work in CIS countries. Two years ago we entered the market of the nearest foreign counties and work very successfully in almost all countries of the post-Soviet Area.

“Cratiya” focuses on health products, which are conventionally divided into three main areas: medicine, medical devices, special food and cosmetics. During the business evolution, many related areas were discovered, despite the major work on registration. Today we offer comprehensive solutions, ranging from production planning in accordance with GMP (Good Manufacturing Practice) to post marketing drug safety researches.

: What does the company name mean?

M. Bagreev: At the time of its creation, the company was called “Cratia” Registration Bureau, shortly “Bureau Cratia” (bureaucracy). Having considered that submission of documents to the state examination from the company, called “Bureau Cratia” (bureaucracy) was not comme il faut, they decided to use the name “Cratiya”.

: How many companies do provide the same services as yours?

M. Bagreev: In medicine registration area we have up to five competitors in Ukraine, but none of them provides such a full range of services. For example, a competitor `s company might not have a lawyer, so the client will have to contact another company to get the legal assistance.

: So are you a monopoly of medicine registration?

M. Bagreev: We have enough competitors, so I would rather call us the leaders in the complex of regulatory work and the quality of its implementation.

: Has your company been affected by the crisis?

M. Bagreev: We passed it without any losses. The crisis is a stress test of the strengths and real viability of the company, and it also gave us a motivation for diversification and development on the foreign markets. And for some pharmaceutical manufacturers, the crisis has not only demonstrated the most stable and priority products, which they have to focus on, but also gave an impact to the development of new directions and opening of new countries.

Innovators continue running.  They bring the most up-to-date drugs that have no alternative. The period from 2013 has opened many opportunities in Ukraine for national producers, which significantly increased the share in the national market and began to actively develop external directions

: What is the complete registration procedure of a new medical product?

M. Bagreev: The registration procedure of a medical product from the moment of documentation work till the time of getting the registration certificate, can take up to one and a half years. Medicine registration process consists of ten thousands of pages of documentation submitted in a strictly “modular” format: administrative data, brief analysis of the main parts of the dossier, the quality of the substance and the final product, preclinical and clinical studies. Documents are drawn up and submitted in accordance with the requirements of Ukrainian legislation.

Developing such national documents as a method of application and methods of quality control, it is necessary not only to comply with the requirements of national legislation, but also not to depart from the original documentation of foreign producers. Administrative documentation, formed legally correctly plays an important role, especially in the mergers and takeovers of pharmaceutical companies

The registration dossier is submitted to the State Expert Center (SEC) of the Ministry of Health of Ukraine, where independent commissions and expert groups conduct an examination within 210 working days. The registration decision is taken at a meeting of the SEC, after which Ministry of Health of Ukraine put the final signature on the Registration Order.

Together with the registration procedure, it is also necessary to confirm that the conditions of production of a medical product comply with GMP requirements. And after obtaining the registration certificate, it is necessary to register imposed layouts of primary and secondary packaging. The State Service of Ukraine on Medicines and Drugs Control has to meet the GMP requirements and registration of packaging of layouts.

: How often do the new drugs come to Ukraine? 

M. Bagreev: Quite often. There are two types of drugs in the pharmaceutical market: the original (innovative) and generics (analogues of already existing drugs). The original product receives the right of exclusivity for 5 years after the first registration, and with proper patent protection – for a period of 15 years, during which the original product`s company is a monopolist. At the end of the period of exclusivity some analogues may enter the market, which will take the whole market share at the expense of reduced cost and active promotion. Often the companies of original products take a decision about new drugs implementation into the Ukrainian market very quickly, usually within a year after its approval in the EU or the United States. LDaily: Maxim, describe the modern business environment in Ukraine. M. Bagreev: In 2014, Ukraine chose a strategic direction for European integration, which was the key to cultural change in society and in business. Much more transparent and accessible is the process of communication with government authorities.

Due to the active position of the Ministry of Health, the State Expert Center, and the relevant Associations, Ukrainian legislation on registration, quality assurance and safety monitoring of medicines is the most approximated to the legislation of Europe in comparison with the CIS countries. Harmonization of the legislation sets those game`s rules that are understandable for foreign companies, which brings innovators and qualitative analogues to the market.

For many foreign companies Ukraine is becoming the first step  to the markets in post-Soviet countries

: What is the hardest thing in your work?

M. Bagreev: It is important for the company to look a few steps forward and make the right strategic decisions today in order to work confidently tomorrow. Therefore, it is so important in the regulatory business to monitor changes not only in Ukrainian but also in European legislation.

For me, as a top-manager of a fast-growing company, the personal challenge was the ability to delegate operational activities and division of business processes in the company.

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