About Us
Pharma Navigation
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.
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.
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.
Our Approach
Regulatory risk management for pharmaceutical and life sciences companies;
Development of clear and predictable regulatory strategies;
Lifecycle regulatory support throughout the entire product lifecycle.
Pharma Navigation
Pharma Navigation helps clients enter the market efficiently and correctly, minimizing the risks of delays, refusals, or sanctions from regulatory authorities.
We focus on long-term partnerships, where clients receive not merely formal compliance support, but a reliable regulatory advisor.
Our Values
Team
Holds two higher education degrees — 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.
From 2022–2026 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).
Since 2019 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.
A practicing attorney admitted to the Bar Council of the Odesa Region (Ukraine).
Has over 12 years of experience in regulatory affairs within the pharmaceutical and medical sectors. Specializes 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. Has practical experience coordinating international regulatory projects with EU and Asian manufacturers, interacting with Ukrainian regulatory authorities, and obtaining and maintaining GMP certificates. Works with the full registration lifecycle, including documentation review, variations management, labelling preparation, packaging design registration, and renewal procedures. Fluent in English and German, holds a degree in Philology, and has experience translating regulatory and technical documentation.
Holds a medical degree and has over 15 years of experience in pharmacovigilance and regulatory support of medicinal products. Worked 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. Since 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. Has practical experience communicating with regulatory authorities on drug safety matters and implementing new pharmacovigilance legislative requirements. Certified Quality Management Specialist (ISO 9001:2015) and pharmacovigilance professional.
Jurisdictions covered
