Partnership
By partnering with Pharmalicensing One, LLC, you can help to bring value to patients and deliver innovative products.
We aim to identify opportunities to build our portfolio and to bring innovative products to patients, covering Rx, OTC, consumer health, dietary nutritional supplements, medical cosmetics, and medical devices; across Russia and ex-USSR, targeted at both private and procurement market segments.
Our expertise covers a range of therapy areas in which we have developed strong partnerships with regulators, payors, providers and healthcare professionals.
We believe in establishing transparent and mutually beneficial relationships, exploring flexible and profitable business models for all parties; whilst maintaining and growing our partnerships through shared vision.
We aim to identify opportunities to build our portfolio and to bring innovative products to patients, covering Rx, OTC, consumer health, dietary nutritional supplements, medical cosmetics, and medical devices; across Russia and ex-USSR, targeted at both private and procurement market segments.
Our expertise covers a range of therapy areas in which we have developed strong partnerships with regulators, payors, providers and healthcare professionals.
We believe in establishing transparent and mutually beneficial relationships, exploring flexible and profitable business models for all parties; whilst maintaining and growing our partnerships through shared vision.
We also operate in global markets such as the EU, APAC, MENA, South America, South Africa, Israel.
We concluded biosimilar and medical devices deals in those markets, scoring the number of deals concluded overall 30+ since 2011.
PhL1 follows superior business ethical standards all across its business process – from initial negotiations to transactions and further delivery. A focus on IP, no risky or complex assets, all operations are transparent and manageable.
We concluded biosimilar and medical devices deals in those markets, scoring the number of deals concluded overall 30+ since 2011.
PhL1 follows superior business ethical standards all across its business process – from initial negotiations to transactions and further delivery. A focus on IP, no risky or complex assets, all operations are transparent and manageable.
Pharmalicensing One, LLC (PhL1) key facts
Business Development
Pharmalicensing One, LLC is a BD&L and M&A experts on a single sector: healthcare. With our team of BD&L and M&A experts and extensive network across Russia and Post-Soviet World we help our partners to ensure the profitableness of their products.
In-Licensing & Asset Scouting
Out-Licensing, Partnering & Deal-making
Out-Licensing, Partnering & Deal-making
We provide professional services (in/out-licensing products / patents / technologies / developments services / distributor search services) to international companies for business in ex-USSR, since 2011.
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In the ex-USSR territory, the major market is Russia accounting for 85%+ value out of that part of ex-USSR
3
We collaborate directly with the МАН and all legal agreements get signed with the Licensor/MAH.
5
We have concluded 80+ licensing agreements, including distribution agreements, product portfolio sale, factory sale and other IP and assets in ex-USSR.
2
Our clients in Russia are mainly international companies along with local top companies who now bloom in development actively growing and investing in product/process development coupled with product in-licensing with API supply and technology acquisition.
4
We do projects which we believe are feasible for us upon we complete a perspective study for those projects.
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RA
Solutions Product-wise
PhL1 provides regulatory services to ensure your Products are licensed or distributed seamlessly in compliance with healthcare regulations across the territory. We have a team of RA associates across ex-USSR, and work closely with our clients to make the regulation process and compliance as stress-free as possible.
Pharmaceuticals, biotech, API
Medical Device and Medical Equipment
Dietary Nutritional Food Supplements (DNFS)
Food for Special Medical Purposes (FSMP)
Cosmetics
Medical Device and Medical Equipment
Dietary Nutritional Food Supplements (DNFS)
Food for Special Medical Purposes (FSMP)
Cosmetics
PhL1 navigate you through regulation by supporting you every step of the route from registration feasibility, market access appraisal and benchmark your brand against the market competitors to product approval and beyond.
Regulatory Affairs
As a proven and trusted Regulatory Affairs partner in ex-USSR, we assist MAH and manufacturers to navigate the Regulatory regime in territory to standardize procedures, streamline Regulatory submissions for drug and medical device classifications (most demandable service in EAEU), their registrations, licensing and obtaining market approvals in the Territory.
With a widely distributed consultant network, we offer a path to approval of healthcare products across multiple jurisdictions.
Our RA consultants enable Pharma and Bio-Med, Life Sciences, Consumer companies to understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in ex-USSR to successfully launch their products in new markets and maximize their market value.
With a widely distributed consultant network, we offer a path to approval of healthcare products across multiple jurisdictions.
Our RA consultants enable Pharma and Bio-Med, Life Sciences, Consumer companies to understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in ex-USSR to successfully launch their products in new markets and maximize their market value.
Our Expertise:
- Regulatory Consulting, Feasibility of the registration country-wise, Regulatory
- Submission Dossier Management and Tracking
- EAEU / UZ /KYR GMP MA Application (MAA)
- Regulatory Submission Road Maps/Regulatory Intelligence Services
- Regulatory Compliance and GAP Analysis
- Pharmaco- & Medical Device Vigilance
- Lifecycle Management (LCM) incl. Renewal and Variations
- Labeling and packaging compliance
- Authorised representative services
- Regulatory Staffing Services
IP
IP protection is a critical pre-requisite for innovation to thrive in the territory of ex-USSR. The EU has developed a unique IP regime for medicines and medical devices. Ex-USSR incl. EAEU nations out of the EU, Ukraine, and Moldova, follow national guidelines. That creates complexity in enetering those markets. We deliver professional IP tailored advisory services to Pharmaceutical, Biotechnology, Medical Device and Healthcare Service companies, namely:
1) Intellectual property (IP) scouting is a most valuable resource, and its protection is a key to that company's future success.
2) Asset valuations and deal structuring to develop win-win scenarios for both the Licensor and Licensee resulting in the timely closing of transactions/deals.
3) Working with investors including private equity funds and investment banks intent to manage and operationalize asset acquisitions within newco’s.
4) Deliver comprehensivedue IP diligence activities in regulatory and medical information and pharmacovigilance.
5) Counsel on trademark licensing, working hand-in-hand to establish licensing programs to monetize trademark portfolios. IP strategy development.
1) Intellectual property (IP) scouting is a most valuable resource, and its protection is a key to that company's future success.
2) Asset valuations and deal structuring to develop win-win scenarios for both the Licensor and Licensee resulting in the timely closing of transactions/deals.
3) Working with investors including private equity funds and investment banks intent to manage and operationalize asset acquisitions within newco’s.
4) Deliver comprehensivedue IP diligence activities in regulatory and medical information and pharmacovigilance.
5) Counsel on trademark licensing, working hand-in-hand to establish licensing programs to monetize trademark portfolios. IP strategy development.
Solutions by Scope of Work
Ex-USSR
In the former USSR, centrifugal forces oriented towards Russia have been preserved, which are intensifying in the current situation.
Solutions by Geography
By choosing competence and geographical area, PhL1 will help you to find the optimal solution and we offer you to help contacting and define your special team to solve strategic problems in the territory. We provide expert level services in ex-USSR markets except for the Baltics and Ukraine. Select your target geographical location:
EAEU
Eurasian Econoic Union (EAEU) is an organization of Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan. It is an economic and custos union similar to the EU in early stages of development. It has its own legislation.
Important: all pharmaceuticals and medical devices have to go through the EAEU regulatory procedure, and the universal EAEU MA certificate is granted. It is recognized in all 5 countries members of the EAEU. That procedure is simlar to the EU DCP one with RSM in one of member countries. EAEU GMP certificate is compulsory (valid 3 years) for MA certificate issuance in the EAEU. Foreign GMP certificates are not valid.
Russian Market at a Glance.
1) Top attractive market in the EAEU. 150+ mln residents, 4th economy worldwide (as per World Bank PPP ranking 2024).
2) Russian medical device market is in global top 15 list. Pharma – in top 10 global list as per IQVIA.
3) Russian market keeps growing in value, estimated to keep growing for next 3 — 5 years.
4) Strong contributing factors: acquisition of new territories and migration influx.
Important: all pharmaceuticals and medical devices have to go through the EAEU regulatory procedure, and the universal EAEU MA certificate is granted. It is recognized in all 5 countries members of the EAEU. That procedure is simlar to the EU DCP one with RSM in one of member countries. EAEU GMP certificate is compulsory (valid 3 years) for MA certificate issuance in the EAEU. Foreign GMP certificates are not valid.
Russian Market at a Glance.
1) Top attractive market in the EAEU. 150+ mln residents, 4th economy worldwide (as per World Bank PPP ranking 2024).
2) Russian medical device market is in global top 15 list. Pharma – in top 10 global list as per IQVIA.
3) Russian market keeps growing in value, estimated to keep growing for next 3 — 5 years.
4) Strong contributing factors: acquisition of new territories and migration influx.
EAEU Population
185+ Mio
GDP (PPP)
Total US$6.921 trillion
Per Capita
$31,200
Population
Moldova
Population
Population
Population
2,512,758 (139th)
Population
Population
3,688,647 (126th)
10,353,296 (90th)
36,024,900 (40th)
GDP (PPP)
10,077,600 (92th)
GDP (PPP)
GDP (PPP)
Total $42.217 billion (132nd)
GDP (PPP)
GDP (PPP)
7,057,841
GDP (PPP)
Per Capita
Total $82.210 billion (101st)
Total $192.146 billion (79th)
Per Capita
Per Capita
Total $53.679 billion (119th)
$16,915 (94th)
Per Capita
Per Capita
Total $371.646 billion (58th)
Total $126.132 billion (93nd)
Per Capita
$22,357 (75th)
$5,360 (148th)
$18,694 (87th)
$10,316 (124th)
$19,938 (80th)
Georgia
Azerbaijan
Uzbekistan
Tadjikistan
Turkmenistan
EU regulatory guidelines.
A small market with a simple and fast MA procedure for products sourced from the EU, UK, Japan, S.Korea, USA, Canada and ANZ.
A simple and fast procedure.
A simple and relatively fast procedure.
A fast track procedure is available for products sourced from 26 countries (EU, UK, ANZ, USA, Canada, Japan, S.Korea).
A simple procedure. If changes in the file to be introduced, a new MA procedure will have to be performed.
Consulting
The global generic drugs market was valued at $385.3 billion in 2022, and is projected to reach $835.7 billion by 2032, growing at a CAGR of 8.1% from 2023 to 2032.
The Global Pharmaceutical Market
The global pharmaceutical market size was estimated at USD 1,559.53 billion in 2023 and it is expected to surpass around USD 2,832.66 billion by 2033. The pharmaceutical market is expanding at a CAGR of 6.15% from 2024 to 2033. The pharmaceutical market is a vital component of the healthcare industry, responsible for the research, development, production, and distribution of medications and medical treatments. It plays a crucial role in improving public health outcomes by providing essential drugs for the prevention, treatment, and management of various diseases and medical conditions.
(Source: Vision Research Reports)
(Source: Vision Research Reports)
Russian Pharma Market at a Glance
The Russian market in the biggest in ex-USSR, andranks Top 10 global pharmaceutical market. The volume of the pharmaceutical market in Russia in 2023 amounted to RUB 2,578 billion (equal to USD 28.3 billion), which is only 0.3% more than in 2022. For the second year in a row, public procurement is growing slower than the commercial market, which remains the driver of overall growth.
In 2024, the Russian pharmaceutical market grew by 10% in value terms to 2.85 trillion roubles ($33,93 billion), which was mainly due to the growth of it commercial segment, where the growth of sales was equivalent to 13.8%.
In 2024, the Russian pharmaceutical market grew by 10% in value terms to 2.85 trillion roubles ($33,93 billion), which was mainly due to the growth of it commercial segment, where the growth of sales was equivalent to 13.8%.
Consulting
We, at PhL1 can define Competitive Intelligence Market Analysis (CIMA) as the aggregation or analysis of competitive intelligence in a way that furnishes your product/development/license with a comprehensive understanding, value proposition, capabilities, and weaknesses versus competitors.
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Demographic trends as aging populations and increasing life expectancy, drive higher demand for pharmaceutical products.
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Recent Russian healthcare reforms have helped increase the use of generics with off-patent drugs helping to add to the increased market size.
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Advances in biotech, novel products development along with generics and generics plus contirdute to the expansion of the Russian pharmaceutical market.
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Russian government policies to support local manufacturing and localization, increasing healthcare spendings.
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Furthermore, demographic trend due to incorporating of new and neighboring regions with rising healthcare expenditures, support greater investment in healthcare infrastructure and drugs provision.
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The increasing prevalence of lifestyle-related diseases, such as diabetes and cardiovascular disorders, creates sustained demand for pharmaceutical interventions and therapeutics.
The following factors contribute to the growth of the Russian pharmaceutical, namely:
