Pharegis is an independent, founder-led regulatory consultancy for pharmaceutical, biotech and MedTech projects in complex markets.
Areas of Expertise
From market-entry decision to maintained authorization.
Pharegis supports regulatory programmes as connected business-critical workstreams, not isolated submission tasks.
Entering the EAEU is not a single regulatory event. Product eligibility, dossier readiness, manufacturing compliance, evidence requirements, submission strategy, authority interaction and post-approval obligations form one connected programme.
Pharegis supports international pharmaceutical, biotech and MedTech manufacturers across that programme — from the first regulatory assessment to registration, inspection readiness and ongoing lifecycle maintenance. An engagement can cover one defined workstream or a broader in-market regulatory function, depending on the client's internal capabilities and local presence.
Our experience with the Russian healthcare regulatory system extends across the Ministry of Health, Federal Service for Surveillance in Healthcare (Roszdravnadzor), the Scientific Centre for Expert Evaluation of Medicinal Products (FSBI SCEEMP) and related regulatory processes. We combine regulatory planning with practical execution and conduct authority interactions within applicable legal, ethical and anti-corruption standards.
Medicinal Products & Lifecycle
Market authorization of medicinal products in the EAEU, API registration in Russia, dossier alignment, variations and post-approval lifecycle management.
- Registration of Drug Products in Russia and the Eurasian Economic Union (EAEU)
- Registration of Active Pharmaceutical Ingredients (API) in Russia
- Registration of drug products and API registration dossier variations
GMP & Inspections
EAEU GMP strategy, inspection readiness, documentation review, inspection support, remediation and follow-up across the manufacturing-compliance workstream.
Medical Devices
Regulatory pathway assessment, technical and clinical documentation, evidence requirements, registration and post-registration support.
Clinical & Preclinical Studies
Regulatory assessment, study requirements, protocol and documentation support, and coordination of evidence generation required for registration.
- Clinical Studies Required for Drug Registration (BE, TE and local Phase III)
- Clinical Studies for Medical Devices
- Preclinical Studies for Drug Registration
- Preclinical Studies for Registration of Biosimilars and Biopharmaceutical Products
Regulatory Consulting
Feasibility assessment, gap analysis, pathway selection, authority strategy, regulatory risk assessment, timelines and resolution of non-standard or high-complexity issues.
Regulatory support without building a local function
For manufacturers entering the EAEU without an established regulatory team in the region, Pharegis can coordinate the regulatory workstream across registration, GMP, dossier maintenance and post-approval changes. For established multinational organisations, the same model can be used selectively for specialist projects, local execution, remediation, workload peaks or complex lifecycle activities.
Entering the EAEU without a local regulatory team
Initial assessment → dossier gap analysis → regulatory pathway → GMP readiness → submission → authority follow-up → approval → variations & maintenance.
Specialist support for complex local workstreams
Complex local issue → expert assessment → local execution → authority strategy → remediation or submission → hand-back or ongoing support.
Registration feasibility, budget and timeline assessments can be scoped independently. Review the regulatory strategy and consulting approach or discuss a project with Pharegis.
Market entry. Regulatory control. Lifecycle continuity.
Values
Our values are applied as working rules rather than statements of intent.
Pharegis applies these principles to everyday regulatory decisions, communication and project execution.
Accuracy
Regulatory advice should distinguish facts, interpretation and assumptions. When uncertainty exists, it should be visible rather than hidden behind confidence.
Integrity
Our advice and interactions with authorities are conducted within applicable legal, ethical and anti-corruption standards. A convenient answer is not useful if it cannot be defended.
Accountability
Commitments require ownership. Material risks, dependencies and changes in assumptions are raised early enough for the client to act on them.
Clarity
Complex regulation does not require complicated communication. Recommendations should state what matters, why it matters and what decision follows.
Confidentiality
Regulatory programmes frequently involve commercially sensitive information. Confidentiality is treated as part of project discipline, not as an administrative formality.
Advantages
A regulatory operating model built for remote markets.
Pharegis structures regulatory execution around senior judgment, local continuity and proportionate control.
Our delivery model is designed for manufacturers that need reliable local regulatory execution without reproducing a full regulatory organisation in every market, and for established global teams that need senior specialist support on complex or non-standard workstreams.
Senior judgment stays in the project
Regulatory decisions are not separated from their execution. Senior leadership remains directly involved when the pathway, evidence, authority response or project assumptions require judgment.
Regulation in its business context
We assess regulatory decisions together with their implications for timing, manufacturing, supply, packaging, clinical development and product lifecycle. A formally compliant route is not necessarily the most useful route for the business.
Complexity translated into decisions
Clients should not have to reproduce the work of their regulatory advisers. We structure complex requirements into clear options, dependencies, risks and next actions — with enough detail to support a decision, but without unnecessary process around the process.
Control without bureaucracy
Projects are built around defined responsibilities, milestones and escalation points. Communication is kept proportionate to the decision being made, allowing teams to move quickly without sacrificing regulatory control.
Local execution without unnecessary local infrastructure
A manufacturer should not need to recreate a full regulatory organisation in every market it enters. Where the project scope allows, Pharegis provides the local regulatory execution and continuity required to move a product through registration and subsequent lifecycle activities.
Continuity beyond approval
Market authorization is the beginning of regulatory maintenance, not the end of the assignment. Variations, renewals, manufacturing changes, GMP status and evolving EAEU requirements can materially affect a product after approval. We therefore design registration work with the subsequent lifecycle in view.
The objective is not only to obtain an authorization. It is to establish a regulatory position that can be maintained.
For a defined workstream or an integrated market-entry programme, contact us to discuss scope, dependencies and the regulatory pathway. For complex or non-standard projects, see our regulatory strategy and consulting approach.
Leadership & Expertise
Founder-led. Senior-led by design.
Pharegis keeps substantive regulatory judgment close to the client and to the work.
The firm is led directly by its founder, with complementary senior capability in business development, external affairs and institutional communications. The model is deliberately compact: critical regulatory decisions are not transferred through multiple management and delivery layers.
Founder & Managing Director
Ruslan Kuchumov, M.D., Ph.D.
Ruslan Kuchumov has worked in pharmaceutical regulatory affairs, clinical development and regulatory project management since 2001. His experience covers medicinal products, biologics, vaccines, APIs and medical devices across Russia, the EAEU and CIS, with particular focus on regulatory strategy, market authorization, CMC, clinical and nonclinical development, GMP and post-approval lifecycle management.
Before establishing Pharegis, he held regulatory and clinical roles with Eli Lilly, Solvay Pharmaceuticals, Janssen, Sanofi Pasteur, Raifarm and Biocodex. Since 2015, he has also provided independent senior regulatory consultancy to Parexel on complex Russia/CIS matters.
Medical Doctor — Moscow State University, Faculty of Basic Medicine (2000)
Ph.D., Candidate of Sciences — Pharmacology & Clinical Pharmacology, Moscow Medical Academy
Clinical Pharmacology Residency — Moscow Medical Academy
Vice President, Business Development & External Affairs
Nina Nikolaeva, Ph.D.
Government Relations · Institutional Communications · Market-Entry Engagement
Nina Sergeeva leads business development, external affairs and institutional communications at Pharegis. Her professional background combines more than a decade of government relations, public and media communications, negotiations with public institutions, executive-level event and protocol management, and cooperation with professional and national business associations.
Before joining Pharegis, she built substantial experience working within Russia's federal legislative institutions, alongside senior positions in public relations, analytical and institutional organisations.
Ph.D., Political Science — Peoples' Friendship University of Russia
Moscow State University, Faculty of Political Science — postgraduate study; Political Analysis / International Relations
English and German — fluent · Spanish — upper intermediate
How We Engage
Senior-led by design. Pharegis is structured as a specialist regulatory consultancy rather than a layered delivery organisation. Regulatory strategy, critical technical decisions and material authority responses remain under direct senior oversight throughout the engagement.
Define the regulatory problem
Product, jurisdiction, current status, business objective and immediate constraints are reviewed before the work is scoped.
Product → status → objective → constraints
Build the regulatory workstream
The project is divided into the decisions and dependencies that actually control the outcome — for example CMC, GMP, clinical evidence, submission, authority interaction or lifecycle maintenance.
Questions → dependencies → deliverables → critical path
Keep senior judgment in the project
Strategic and technically material work is led directly by Pharegis senior management rather than transferred through successive sales, project-management and junior-delivery layers.
Add specialist resources where required
Laboratory, clinical, analytical, translation, logistics or other specialist resources can be integrated according to project need while the client retains one regulatory interface with Pharegis.
Preserve regulatory continuity
Authority correspondence, assumptions, decisions and post-approval implications are maintained as part of the regulatory history of the product rather than treated as isolated transactions.
Submission → authority interaction → approval → lifecycle
The right specialist capability without transferring regulatory ownership.
Not every regulatory programme requires every technical capability to exist within one organisation. Pharegis works with selected external specialists and service providers where a project requires laboratory, clinical, preclinical, analytical, statistical, translation, logistics or other specialised execution.
External resources are selected and coordinated according to the scope of the individual project. Regulatory strategy, integration of the workstreams and substantive client communication remain with Pharegis.
Specialist work may be outsourced. Regulatory accountability is not.For market-entry situations where regulatory work alone is not enough.
For selected mandates, Pharegis can complement the regulatory workstream with senior external-affairs support where effective market entry also requires institutional navigation, professional-community engagement or executive-level communication.
- Stakeholder & professional-community mapping
- Executive meeting preparation
- Industry-association engagement
- Conference & exhibition strategy
- Executive briefings & market-entry narratives
- Focused round tables or expert meetings
Representative Engagements
Most Pharegis engagements are performed under confidentiality obligations. Client identities, products and project-specific information are therefore not disclosed. The profiles below describe representative types of regulatory engagements and workstreams rather than individual client case studies.
Commercial API Registration in Russia
Typical situation. An international API manufacturer requires establishment or maintenance of the regulatory status necessary for commercial supply in Russia.
Pathway assessment → CMC / DMF / ASMF gap review → local quality documentation → samples & analytical readiness → GMP interface → submission → lifecycle
EAEU Medicinal Product Market Authorization
Typical situation. An originator, generic, biosimilar, vaccine or other medicinal-product manufacturer needs a defensible EAEU registration pathway and controlled execution through expertise.
Feasibility → dossier gap → development requirements → submission → expertise → approval → maintenance
Complex Regulatory Pathway & Feasibility
Typical situation. The regulatory question does not fit a standard filing route — for example MAH transfer, fixed combination, orphan product, radiopharmaceutical, innovative biotech product or complex contract-manufacturing model.
Regulatory question → options → evidence gaps → risk / time / cost implications → recommended pathway
CMC & Lifecycle Programme
Typical situation. Manufacturing, site, specification, analytical-method, packaging or other quality changes affect one or more approved dossiers and require coordinated regulatory impact assessment.
Change → impact assessment → classification → dossier alignment → variation → authority response → implementation
Clinical Development for Registration
Typical situation. A manufacturer needs to determine the local evidence strategy and translate it into an executable clinical, bioequivalence or related registration programme.
Requirement assessment → study strategy → protocol / documentation → regulatory process → execution coordination → registration interface
GMP Inspection & Manufacturing Compliance
Typical situation. A foreign manufacturing site needs EAEU GMP inspection readiness integrated with the product registration or API workstream.
Gap assessment → readiness plan → documentation → inspection support → CAPA / remediation → regulatory follow-through
Medical Device Regulatory Programme
Typical situation. A manufacturer needs a Russia/EAEU device pathway covering classification, evidence, documentation, submission and post-registration obligations.
Pathway → evidence → technical documentation → submission → authority interaction → lifecycle
A representative pathway is a starting point, not a fixed package. Scope is defined around the product, jurisdiction, evidence position, existing internal capability and the decisions that actually control the project.