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Enter the Ukrainian Market. Fast and Without Mistakes.
Enter the Ukrainian Market. Fast and Without Mistakes.
We handle registration, regulatory support and the commercial launch of your product, from the first document to the first sale.
the challenge
Registration in Ukraine Is Complex – Especially the First Time.
Registering a medicine in Ukraine requires deep knowledge of local legislation, the Ministry of Health, regulatory procedures and market specifics. Most international manufacturers run into the same barriers:
Long registration timelines due to unfamiliarity with local requirements
Long registration timelines due to unfamiliarity with local requirements
Long registration timelines due to unfamiliarity with local requirements
Difficulties preparing documentation in Ukrainian
Difficulties preparing documentation in Ukrainian
Difficulties preparing documentation in Ukrainian
No local partner to represent them before the regulator
No local partner to represent them before the regulator
No local partner to represent them before the regulator
Risk of delays and extra costs from early‑stage mistakes
Risk of delays and extra costs from early‑stage mistakes
Risk of delays and extra costs from early‑stage mistakes
our solution
We Know This Market from the Inside and Work as Your Local Team
Amicum Pharma takes responsibility for every business process in the market, from registration to commercialisation. You focus on innovation, we take care of the entire path to success.
Amicum Pharma takes responsibility for every business process in the market, from registration to commercialisation. You focus on innovation, we take care of the entire path to success.
«From the first document to every sale, we're right there with you»
What's Included in the Service
We cover the entire regulatory and commercial cycle, from the first consultation to approval and market launch.
Registration of medicines
Dossier preparation and approval
Dietary Supplement and Medical Device Registration
In line with Ukrainian legal requirements
Regulatory support
Consultations and support handling regulator queries
Local representation before the Ministry of Health
Representing the manufacturer's interests in Ukraine
Market entry strategy
Market analysis and commercial model
Exclusive representation
A full-fledged partner in the Ukrainian market
Registration of medicines
Dossier preparation and approval
Dietary Supplement and Medical Device Registration
In line with Ukrainian legal requirements
Regulatory support
Consultations and support handling regulator queries
Local representation before the Ministry of Health
Representing the manufacturer's interests in Ukraine
Market entry strategy
Market analysis and commercial model
Exclusive representation
A full-fledged partner in the Ukrainian market
Registration of medicines
Dossier preparation and approval
Dietary Supplement and Medical Device Registration
In line with Ukrainian legal requirements
Regulatory support
Consultations and support handling regulator queries
Local representation before the Ministry of Health
Representing the manufacturer's interests in Ukraine
Market entry strategy
Market analysis and commercial model
Exclusive representation
A full-fledged partner in the Ukrainian market
Partnership Formats
Exclusive Distributor
Amicum Pharma becomes the manufacturer's sole official representative in the Ukrainian market: registration, logistics, customs clearance, tender procurement and commercial sales. No need to open a local office.
Registration and regulatory support
Logistics, customs clearance and storage
Tender procurement and commercial sales
Regulatory Partner
We take on product registration and regulatory support with the Ukrainian Ministry of Health. Suited to manufacturers who already have their own sales channels or a local sales partner but need registration expertise.
Registration dossier preparation
Support with the Ministry of Health and relevant authorities
Responses to regulator queries and inspection support
Strategic Partner
Joint development of a market entry strategy: competitive landscape analysis, defining target sales channels, and building a commercial model and roadmap. For manufacturers still deciding whether to enter the Ukrainian market.
Market and competitive landscape analysis
Identifying the optimal sales channels
Building the commercial model and roadmap
Exclusive Distributor
Amicum Pharma becomes the manufacturer's sole official representative in the Ukrainian market: registration, logistics, customs clearance, tender procurement and commercial sales. No need to open a local office.
Registration and regulatory support
Logistics, customs clearance and storage
Tender procurement and commercial sales
Regulatory Partner
We take on product registration and regulatory support with the Ukrainian Ministry of Health. Suited to manufacturers who already have their own sales channels or a local sales partner but need registration expertise.
Registration dossier preparation
Support with the Ministry of Health and relevant authorities
Responses to regulator queries and inspection support
Strategic Partner
Joint development of a market entry strategy: competitive landscape analysis, defining target sales channels, and building a commercial model and roadmap. For manufacturers still deciding whether to enter the Ukrainian market.
Market and competitive landscape analysis
Identifying the optimal sales channels
Building the commercial model and roadmap
Exclusive Distributor
Amicum Pharma becomes the manufacturer's sole official representative in the Ukrainian market: registration, logistics, customs clearance, tender procurement and commercial sales. No need to open a local office.
Registration and regulatory support
Logistics, customs clearance and storage
Tender procurement and commercial sales
Regulatory Partner
We take on product registration and regulatory support with the Ukrainian Ministry of Health. Suited to manufacturers who already have their own sales channels or a local sales partner but need registration expertise.
Registration dossier preparation
Support with the Ministry of Health and relevant authorities
Responses to regulator queries and inspection support
Strategic Partner
Joint development of a market entry strategy: competitive landscape analysis, defining target sales channels, and building a commercial model and roadmap. For manufacturers still deciding whether to enter the Ukrainian market.
Market and competitive landscape analysis
Identifying the optimal sales channels
Building the commercial model and roadmap
Why Amicum Pharma
Why Amicum Pharma
10 Years in the Market
Deep knowledge of the Ukrainian regulatory environment and established relationships with relevant authorities.
10 Years in the Market
Deep knowledge of the Ukrainian regulatory environment and established relationships with relevant authorities.
10 Years in the Market
Глибоке знання українського регуляторного середовища та усталені відносини з профільними органами.
Full Cycle Under One Roof
Registration, logistics, customs clearance, tenders and sales, with no third‑party contractors.
Full Cycle Under One Roof
Registration, logistics, customs clearance, tenders and sales, with no third‑party contractors.
Full Cycle Under One Roof
Registration, logistics, customs clearance, tenders and sales, with no third‑party contractors.
Experience in the Orphan Drug Segment
Over 30 rare disease nosologies. We know how to work with complex products.
Experience in the Orphan Drug Segment
Over 30 rare disease nosologies. We know how to work with complex products.
Experience in the Orphan Drug Segment
Over 30 rare disease nosologies. We know how to work with complex products.
Trusted by International Manufacturers
