Regulatory Affairs in Eurasia, Ukraine and Russia

In Eastern Europe and Eurasia, the growing focus on specialized medicines emphasizes the importance of policy in determining access to these drugs within their intricate healthcare systems.

For 25+ years bridging West and East, Delta Medical created pathways through exacting submission requirements otherwise preventing patient reach of breakthrough innovations.

We directly ease market access through registering pharmaceuticals, biologics, medical devices and equipment, FSMP’s, disinfectants, cosmetics and supplements – allowing for promising healthcare possibilities.

Specialized Therapeutic Guidance Across 13 Distinct Markets

Operating directly supporting manufacturers in Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Russia, Tajikistan, Turkmenistan, Ukraine and Uzbekistan – our teams enable regional enhancement spanning:

  • Oncology advances improving survival odds
  • Gene therapies correcting rare afflictions
  • Precision antibiotics overcoming drug resistance
  • Consumer healthcare for the most common complaints
  • FSMP’s for various metabolic diseases
  • Enhanced nutraceuticals with complex compositions

“In countries representing the nexus between East Europe and Eurasia, complexity abounds but through collaboration with our global partners, access is improved.”

 William Wickham, Corporate Affairs, Delta Medical

Delta Medical Disease Area Registration Breadth

Therapeutic IndicationSample Modalities Supported
Rare DiseasesGene, RNA, Cell Therapies
OncologyBiologics, antibody-drug conjugates, CAR T-cell therapies, immunotherapies
Infectious DiseasesNovel Antimicrobials, Vaccines, Phage Tx
Metabolic DisordersEnzyme replacement therapies, protein therapies
Women’s HealthMicrobiome-based therapeutics, long-acting contraceptives
Pediatric MedicinesPrecision antibiotics, abuse-deterrent formulations

Harmonizing policy controls, access guidelines and cultural wisdom into localized form furthering availability.

Expedited Regulatory Submissions Despite Market Challenges

Delta Medical’s regulatory affairs leaders directly shepherd partners’ registration, licensing, site clearances and maintenance – serving as unified localization specialists via proximity to competent authorities nurturing personal relationships that expedite access.

“The value of partnerships premised upon trust”

-Anton Galyuchok, Head of Regulatory Affairs, Delta Medical

Our comprehensive regulatory offerings include:

Market Entry Navigation

  • Requirements intelligence to shape strategic plans
  • Dossier authorship via category experts handling intricacies
  • Label compliance and translation spanning 14 regional languages

Since 2000, directed 436+ niche medicine and device approvals – preventing common yet avoidable delays through specialized understanding of latest science and corresponding terminology.

Post-Launch Compliance Assurance

  • Multi-country license maintenance activities tracking
  • Label, packaging and specification update authorizations
  • Site change clearances sustaining supply integrity
  • Relationship and renewal continuity establishing guardrails

Thus availability improves as innovation endures through oversight minimizing disruptions via proactive regulatory alignment at all stages.

Delta Medical Disease Area Registration Breadth

CategoryKey Documents Prepared
New MedicineClinical Overviews, GMP Certs, Local Labeling, Prescribing Info
Medical DevicesTechnical Documentation, Product Specifications, Clinical Evaluations, IFUs
Medical EquipmentSafety Testing Data, Electrical Safety Reviews, EMT type testing
Food for Special Medical PurposesFormulation Details, Nutritional Composition, Claims Dossiers
Disinfectant ProductsEfficacy Testing, Toxicology Studies, Safety Specifications

4.500+ pages authored in collaboration with our global partners expedites medical access through document preparation.  Combining the possibility with local practicality.

Strategic Consulting Guiding Successful Market Entry & Expansion

Initial Target Country Selection & Launch Readiness

  • Landscape opportunity analysis on recruitment needs, population data, pricing scenarios
  • Thoughtful positioning respecting cultural mores around communications
  • Enable smooth applications through localization leadership

Avoiding blindspots via on the ground proximity while expediting initial availability where need meets innovation.

“What appears administrative abstraction formed by afar becomes understood as public servants seeking certainty for populations relying on our ability to convey therapeutic benefits.”

-Dr. Olesya Coutts, Head of Ukraine Specialty Pharmaceuticals, Delta Medical

Specialized Expertise Navigating Eurasian Economic Union (EAEU) Registration Pathways

The Eurasian Economic Union, consisting of Russia, Kazakhstan, Belarus, Armenia and Kyrgyzstan, established critical Mutual Recognition Agreements (MRAs) between member states expediting aligned medicine and device regulations to ease access spanning across these countries with over 185 million patients.  These mutual recognition agreements are still relatively new and in the process of implementation and adaptation.
Delta Medical regulatory professionals provide dedicated support navigating this specialized EAEU registration pathway, including:

Medicines Registration

  • Registration certificates in one member state enabling abbreviated submissions in additional countries, avoiding duplicative assessments
  • Mutual recognition of Good Manufacturing Practice (GMP) certifications across EAEU, further optimizing processes

Medical Devices

  • Recognition of conformity assessments for authorization in multiple countries
  • Facilitating placement of Eurasian Conformity (EAC) mark to enable regional circulation

Backed by deep EAEU policy expertise, Delta Medical has directed several niche therapies through these MRA registration pathways – expanding reach up to 34% faster than individual country applications.

Complementary Capabilities Bridging Post-Approval Stages

Scientific Communications & Medical Affairs
Our field-based teams foster partnerships facilitating clinical trials and real-world evidence studies to demonstrate localized value:

We ensure implementation upholds ethics while conveying innovation applicability to authorities determining access outcomes.

Ethical Evidence Generation

Delta Medical’s field-based Medical Science Liaisons provide vital medical affairs capabilities guiding research demonstrating treatment breakthroughs meeting needs of overlooked populations often excluded from clinical trials historically run elsewhere.

Our scientific and research support activities include:

Perspective to Policy: Advancing Access Through Leadership Engagement

Once advisory panels review validity of value claims, securing public reimbursement requires addressing the fiscal framers controlling funding flows behind the scenes.

Delta Medical offers dedicated capability consulting with Health Technology Assessment (HTA) and payer decision makers through:

Supply Chain Enabling Availability

With approvals secured, robust infrastructure sustains flows of innovations relied upon daily by doctors, pharmacists and those seeking not just extensions but enhanced qualities of life.

Delta Medical provides integrated distribution solutions upholding integrity from customs through to last mile care settings:

Committed to Conveying Care, Together

At Delta Medical, we believe patient fates shouldn’t be determined by borders or policy barriers preventing innovation.

Speeding up new drug market entry means tackling complex access issues promptly. This avoids assumptions that delay availability, crucial for turning ideas into local solutions.

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