iPHARMAUNION the local operating partner and navigator for biopharmaceutical projects entering clinical practice in Russia.
Turning international biopharmaceutical strategies into local clinical execution.
Between a strategic decision and a medicine reaching clinical practice lies a complex system of regulatory, clinical, and operational challenges.
For international pharmaceutical and biotechnology companies, local execution can become the critical bottleneck.
Regulatory requirements, access to clinical centers, stakeholder coordination, patient pathways, logistics, and local operational practices all need to work together.
iPHARMAUNION is a local operating partner for complex biopharmaceutical projects in Russia.
We help international companies navigate the local regulatory and clinical environment, translate global strategies into practical actions, and coordinate the key elements required to move innovative therapies toward clinical practice.
Our focus is on oncology, hematology, and advanced therapies, where successful execution requires specialized expertise, established clinical relationships, and precise coordination.
We connect international strategy with local execution.
Request feasibility assessment
FROM STRATEGY TO CLINICAL PRACTICE
International development programs are designed globally.
Their implementation is local.
A successful project requires more than a strong scientific rationale and a complete regulatory dossier. It requires an understanding of the local healthcare system, regulatory environment, clinical infrastructure, and professional practices.
iPHARMAUNION provides the local capability needed to bridge this gap.
Regulatory Environment
We develop practical regulatory strategies adapted to the Russian regulatory framework and support interaction with relevant authorities throughout the project lifecycle.
Clinical Infrastructure
We facilitate access to specialized clinical centers and support engagement with investigators and research teams.
Stakeholder Coordination
We coordinate communication and activities between international sponsors, CROs, manufacturers, investigators, healthcare institutions, and other project stakeholders.
Local Execution
We translate international development plans into concrete local actions and provide operational oversight throughout implementation.
OUR EXPERTISE
Oncology
Supporting complex oncology programs from regulatory planning and clinical feasibility to trial execution and local coordination.
Hematology
Specialized experience in hematological malignancies, including lymphoma and other complex hematology programs.
Advanced Therapies
Operational expertise supporting complex therapeutic approaches, including cell therapy , where clinical, regulatory, manufacturing, and logistics requirements must operate as one integrated system.
Clinical Trials
From feasibility and site identification to regulatory support, site activation, investigator coordination, patient pathways, and study execution.
Regulatory Affairs
Practical regulatory strategy, clinical trial authorization, medicinal product registration, regulatory interactions, and local regulatory support.
COMPLEX PROJECTS REQUIRE LOCAL EXPERTISE
A single point of local responsibility.
For an international sponsor, managing a project in a new regulatory and clinical environment can create multiple interfaces and operational risks.
iPHARMAUNION provides a single local point of coordination connecting international project teams with the Russian clinical and regulatory environment.
We understand both sides:
the international logic of biopharmaceutical development
and
the practical realities of local execution.
This allows us to identify potential bottlenecks early, coordinate the relevant stakeholders, and turn strategic decisions into actionable local plans.
SELECTED EXPERIENCE
CELL THERAPY
International clinical development program focused on CD19-positive refractory/relapsed lymphomas.
iPHARMAUNION supports the local implementation of the program across regulatory, clinical, operational, and stakeholder coordination activities.
Key areas include:
Regulatory strategy
Clinical trial operations
Hematology center coordination
Patient pathway
Cell collection and logistics
Operational coordination
WHY iPHARMAUNION
LOCAL KNOWLEDGE
Deep understanding of the Russian regulatory, healthcare, and clinical environment.
INTERNATIONAL PERSPECTIVE
Ability to translate international development strategies into practical local execution.
SPECIALIZED EXPERTISE
Focus on oncology, hematology, and complex therapies.
CLINICAL CONNECTIONS
Established interaction with specialized clinical and research institutions.
OPERATIONAL RESPONSIBILITY
One local team coordinating the critical elements required to move a project forward.
FROM COMPLEXITY TO ACTION
The objective is simple:
to reduce the distance between an international strategic decision and its successful local implementation.
We support projects where regulatory complexity, clinical infrastructure, stakeholder coordination, and time matter.
Because in biopharmaceutical development, delays have consequences.
And sometimes,
WHERE TIME MATTERS,
LOCAL EXECUTION MATTERS.
LET’S DISCUSS YOUR PROJECT
Request feasibility assessment
Are you planning a clinical development, regulatory, or market-entry project in Russia?
Tell us about your program, and our team will assess the local requirements, potential challenges, and possible execution pathway.
HOW WE WORK
We provide structured execution of clinical trials in EAEU:
- Feasibility assessment
Study evaluation, site availability, recruitment potential - Site selection and activation
Identification of appropriate clinical centers and запуск - Regulatory submission
Preparation and submission to Ministry of Health - Patient recruitment
Coordination with investigators and enrollment support - Monitoring and coordination
Ongoing communication, study tracking, issue resolution - Documentation management
Full handling of study-related documentation
Scope of responsibility
We manage the full local execution of clinical trials:
- Regulatory submission to Ministry of Health
- Site selection and activation
- Patient recruitment
- Monitoring and coordination
- Study documentation management
Acting on behalf of the sponsor, we ensure alignment between clinical sites, regulatory requirements and study timelines.
FROM CLINICAL TRIALS TO REGISTRATION
We support the transition from clinical development to market entry in EAEU.
Based on clinical trial data, we assist with:
- Regulatory strategy for registration
- Dossier preparation
- Interaction with regulatory authorities
- Pharmacovigilance setup
CONTACT
Start with a feasibility discussion for your study.
Request feasibility assessment
Email: center@ipharmaunion.com
Phone: +7 (495) 248-1938