{"id":555,"date":"2026-03-08T01:31:06","date_gmt":"2026-03-07T23:31:06","guid":{"rendered":"https:\/\/www.pharma-navigation.com\/?page_id=555"},"modified":"2026-04-16T02:01:02","modified_gmt":"2026-04-15T23:01:02","slug":"kompaniya","status":"publish","type":"page","link":"https:\/\/www.pharma-navigation.com\/en\/kompaniya\/","title":{"rendered":"About Us"},"content":{"rendered":"
\n\t\t\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t

About Us<\/h1>\t\t\t\t<\/div>\n\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Pharma Navigation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Pharma Navigation is a regulatory consulting company bringing together professionals from various areas of pharmaceutical and medical regulatory affairs. We work with life sciences products, including medical devices, cosmetic products, dietary supplements, and medicinal products.<\/p>

Government regulation of the pharmaceutical market is constantly evolving, and liability for non-compliance is strict and financially significant. For this reason, regulatory affairs is considered a high-risk professional field where mistakes have direct business consequences. Our role is to help clients navigate these risks in a structured and controlled manner and build a stable and compliant market presence.
Pharma Navigation systematically monitors changes in sector-specific legislation, works closely with regulatory authorities and market participants, and continuously enhances the professional competencies of its team. We value client trust and our professional reputation as a key intangible asset.
The company has implemented a Quality Management System in accordance with ISO 9001, ensuring a structured approach to service delivery, process control, and predictable results for our clients.<\/p>

We provide regulatory services in the markets of Ukraine, the Republic of Moldova, Poland, and the Czech Republic, combining in-depth knowledge of national legislation with a strong understanding of European regulatory practice and EU compliance frameworks.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t

\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t

Our Approach<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
We work not only with individual regulatory tasks but with the complete regulatory landscape of a product. Our approach is based on:<\/div>\t\t\t\t<\/div>\n\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Regulatory<\/strong> risk management for pharmaceutical and life sciences companies;<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Development<\/strong> of clear and predictable regulatory strategies;<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Lifecycle<\/strong> regulatory support throughout the entire product lifecycle.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Pharma Navigation<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Pharma Navigation helps clients enter the market efficiently and correctly, minimizing the risks of delays, refusals, or sanctions from regulatory authorities.<\/p>

We focus on long-term partnerships, where clients receive not merely formal compliance support, but a reliable regulatory advisor.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Our Values<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\tRespect for clients\u2019 business objectives<\/strong><\/span> \u2014 we consider the commercial context of each project and propose solutions that combine regulatory compliance with practical business needs.\t\t\t\t\t\t\t\t<\/div>\n\t\t
\n\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t
Professional responsibility<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\tWe undertake only those commitments we are fully capable of delivering.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t
Process transparency<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\tWe ensure clear planning, well-reasoned decisions, and predictable project timelines.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t
Systemic thinking<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\tRegulatory affairs as a structured process, not a set of isolated actions.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Team<\/h2>\t\t\t\t<\/div>\n\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t
SILCHENKO Maksym<\/div>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
Managing Partner, Pharma Navigation<\/div>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
More details<\/div>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Holds two higher education degrees \u2014<\/strong> in Law and in Quality, Certification and Standardization. Fluent in English.
Has experience managing complex multi-jurisdictional regulatory projects, including coordination between manufacturers, distributors, and regulatory authorities. Participated in building and structuring a registration and certification department from scratch, implementing a systematic approach to regulatory risk management and strategic cooperation with foreign manufacturers.<\/p>

From 2022\u20132026<\/strong> he headed the Registration and Certification Department at TOTISPHARMA GROUP, a large international distributor of aesthetic medicine products (cosmetics, medical devices, dietary supplements, and medicinal products).<\/p>

Since 2019<\/strong> he has practical experience in medical device certification, registration and notification of cosmetic products and dietary supplements in the markets of Ukraine, Moldova, Poland, and the Czech Republic. Has experience supporting inspections of medical devices by state market surveillance authorities.<\/p>

A practicing attorney admitted<\/strong> to the Bar Council of the Odesa Region (Ukraine).<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t
Nataliya Morozovska<\/div>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
Regulatory Affairs Expert<\/div>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
More details<\/div>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\tHolds a higher education degree in Chemistry (Inorganic Chemistry) and has over 20 years of practical experience in pharmaceutical regulatory affairs. She began her professional career as an analytical chemist in a pharmaceutical quality control laboratory, specializing in the analysis of APIs and finished dosage forms.\nShe worked as Head and Manager of Regulatory Affairs in international pharmaceutical companies (Arterium, Genom Biotech, Queisser Pharma).\nSince 2009, she has been supporting the registration of medicinal products and dietary supplements in CTD format, including projects for manufacturers from Germany, France, Italy, the Netherlands, Denmark, India, and China, as well as cooperation with leading Ukrainian pharmaceutical manufacturers.\nShe has extensive experience in GMP-related matters, regulatory variations, and international regulatory procedures.\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t
Yana Dovhan<\/div>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
Regulatory Affairs Expert<\/div>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
More details<\/div>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Has over 12 years of experience in regulatory affairs within the pharmaceutical and medical sectors.\nSpecializes in the registration of medicinal products, active pharmaceutical ingredients (APIs), immunobiological medicinal products, dietary supplements, and cosmetic products, including preparation and management of CTD dossiers.\nHas practical experience coordinating international regulatory projects with EU and Asian manufacturers, interacting with Ukrainian regulatory authorities, and obtaining and maintaining GMP certificates.\nWorks with the full registration lifecycle, including documentation review, variations management, labelling preparation, packaging design registration, and renewal procedures.\nFluent in English and German, holds a degree in Philology, and has experience translating regulatory and technical documentation.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t
Valentyna Yeremenko<\/div>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
Pharmacovigilance and Drug Safety Expert<\/div>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
More details<\/div>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t

Holds a medical degree and has over 15 years of experience in pharmacovigilance and regulatory support of medicinal products.\nWorked in key positions at leading Ukrainian pharmaceutical companies (Darnytsia, Kyivmedpreparat, Aurobindo), where she was responsible for establishing and maintaining pharmacovigilance systems, signal management, preparation of PSURs and RMPs, and interaction with regulatory authorities.\nSince 2021, she has been providing services as a Qualified Person responsible for Pharmacovigilance (QPPV equivalent), supporting applicants in risk management, PV system audits, and CAPA development.\nHas practical experience communicating with regulatory authorities on drug safety matters and implementing new pharmacovigilance legislative requirements.\nCertified Quality Management Specialist (ISO 9001:2015) and pharmacovigilance professional.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

\n\t\t\t\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t
\t\t
\n\t\t\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t

Jurisdictions covered<\/h2>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
Jurisdictions we work with<\/div>\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
Regulatory support is provided at national level and within European regulatory systems.<\/div>\t\t\t\t<\/div>\n\t\t
\n\t\t
\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
Czech Republic<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
Ukraine<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
Poland<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\"\"\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t
Republic of Moldova<\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tSend a request<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t
\n\t\t\t\t\t