Independent practice · Moscow · since 2019

Pharmaceuticals · Medical devices

Market access, regulatory & documentation

Russia / EAEU — evidence-led support for life-sciences companies.

An independent Moscow-based advisory helping pharmaceutical and medical-device companies with regulatory documentation, pharmacoeconomic evidence, market analytics and market entry across Russia and the EAEU — active since 2019.

// focus areas MSK ··:··

01Regulatory affairs RU / EAEU
02Pharmacoeconomics · HTA CEA / BIA
03Market analytics data-driven
04Documentation · RU ↔ EN audit-ready
05Public affairs compliant
06Finance · software second track

6 focus areas · RU / EAEU · since 2019

The practice

Independent advisory for life-sciences market access.

A Moscow-based independent consulting practice, active since 2019, supporting pharmaceutical and medical-device companies on commercial strategy, regulatory documentation, pharmacoeconomic evidence and market access across Russia and the EAEU.

Every recommendation is framed in evidence a payer or regulator can act on — with international research channels (including Singapore / ASEAN) available where a question reaches beyond the region.

At a glance

Scope

Pharmaceuticals & medical devices

Geography

Russia / EAEU · international channels

Active since

2019 · independent practice

Based in

Moscow, Russian Federation

Legal status

Sole proprietor (ИП) · ОГРНИП 319774600252261

2019Practising since
10Service lines
2Delivery tracks
RU · ENWorking languages

Services

How we support market access.

A focused set of services for entering and operating in the Russian and EAEU life-sciences market. Exact scope and deliverables are agreed with each client.

01

Regulatory & market-access advisory — pharma

RU / EAEU registration pathways, reimbursement listing (ЖНВЛП) and localisation requirements for pharmaceutical products.

02

Medical-device registration & compliance

Roszdravnadzor and EAEU device pathways — technical files, conformity, and post-market vigilance documentation.

03

Pharmacoeconomics & HTA support

Cost-effectiveness and budget-impact analysis, value dossiers and evidence packages for reimbursement and formulary decisions.

04

Regulatory documentation & translation

Dossier support (including eCTD-aligned structure) and technical / medical RU ↔ EN translation and document preparation.

05

Russian market support

Supplier and CMO identification, contract-manufacturing localisation, and documentation updates to current RU / EAEU requirements.

06

Market research & financial modelling

Market sizing, forecasting, pricing scenarios and decision-ready business cases — segment analysis of the pharma market.

07

Public affairs & stakeholder engagement

Compliant liaison with industry associations and regulatory bodies; international research channels (incl. Singapore) on request.

Distinctive competence

Digital analytics at the IT × healthcare intersection

Interactive dashboards and automated pipelines for collecting and processing data — tenders / ЕИС, customs statistics, open registries — plus predictive models of access and demand. International research channels (incl. Singapore / ASEAN) engaged where needed.

DashboardsTenders / ЕИСCustoms dataRegistriesForecasting

Second track

The same toolkit, beyond life sciences.

Pharma market access is the practice's headline work — and it rests on a broader base: financial modelling, software delivery and data engineering for clients across industries.

08

Financial modelling & analysis

Models for investment programmes and venture portfolios, pricing and unit economics — decision-ready business cases, Excel/VBA automation, dashboards.

09

Software & app engineering consultancy

Full-cycle IT delivery from idea and backlog to production — product & project management, Agile at scale, pre-sale support and rapid prototyping.

10

Data & analytics engineering

Automated pipelines, interactive dashboards and forecasting models — the common technical thread across both tracks of the practice.

Method

Every recommendation framed in evidence.

Three principles run through the work — from the first data pull to the final dossier.

01

Evidence & pharmacoeconomics

Market data, forecasting, cost-effectiveness and budget-impact modelling — decision-ready business cases in numbers a payer can act on.

02

Regulatory & documentation

Accurate, audit-ready dossiers for pharmaceuticals and technical files for devices — with translation and localisation aligned to RU / EAEU requirements.

03

Access & engagement

Compliant stakeholder engagement built on transparent, association-led channels — and international research where a question needs it.

The toolkit behind the analytics.

A working constellation of the regulatory frameworks, evidence methods and data sources the practice moves between — the vocabulary of market access, rendered live.

Track record

Delivered in Russia, connected internationally.

Representative engagements across regulatory documentation, sourcing, analytics and international research.

Russia / EAEU regulatory

Pharma localisation & dossier advisory

Advised Russian pharmaceutical clients on registration dossiers, contract-manufacturing localisation, and documentation updates to current RU / EAEU requirements.

DossierLocalisationEAEU
Russia / EAEU market

Sourcing & market support

Supplier and partner identification in pharma manufacturing, with support for customers updating product documentation and navigating EAEU procedures.

SourcingCMOCompliance
International research

Contract research coordination

Coordinated contract research with international partners across Southeast Asia, including engagement with a national research agency and a national innovation programme.

Southeast AsiaContract R&DInternational
Analytics modelling

Market analytics & forecasting

Segment sizing and demand scenarios for the pharma market, built on automated data pipelines (tenders / ЕИС, customs statistics, registries) and interactive dashboards.

ForecastingDashboardsHTA

Let's talk

Discuss your market-access needs.

Registration, dossiers, HTA evidence, market analytics, or documentation that has to hold up under review — I'm easy to reach.

Write email

EntityИП Митрохин Евгений Максимович ОГРНИП319774600252261 ИНН773433517310 ОКВЭД70.22 LocationMoscow, RF