Regulatory support for health-related products in Ukraine and the EU.
Regulatory consulting covering the registration of medicinal products, certification of medical devices, notification of cosmetic products, and registration and notification of dietary supplements, in line with Ukrainian and European Union regulatory requirements.
Medicinal product registration, GMP compliance and pharmacovigilance
Full support for bringing drugs to market: from preparing registration dossiers and GMP audits to setting up pharmacovigilance systems
Cosmetic product notification and regulatory support
Comprehensive preparation of technical documentation and product notification for the legal sale of cosmetics in accordance with regulations.
Medical device certification and regulatory compliance
Professional assessment of medical devices' compliance with technical regulations, including the creation of technical files and verification of labeling.
Dietary supplement registration and notification
Rapid notification and examination of additives to confirm their safety and successful launch.
SILCHENKO Maksym
Managing Partner
Pharma Navigation
— is a regulatory consulting team specialising in pharmaceutical and medical regulatory affairs.
Our work combines practical experience with life sciences products and a structured understanding of regulatory frameworks, supporting market entry across different jurisdictions.
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Jurisdictions covered
Jurisdictions we work with
Regulatory support is provided at national level and within European regulatory systems.
Czech Republic
Ukraine
Poland
Republic of Moldova
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Do you require regulatory support?
Please submit your enquiry, and we will contact you to discuss your project and the most appropriate regulatory approach.