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

For 296+ million lacking alternatives across cancers, chronic conditions and stretched health systems.

“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 Indication	Sample Modalities Supported
Rare Diseases	Gene, RNA, Cell Therapies
Oncology	Biologics, antibody-drug conjugates, CAR T-cell therapies, immunotherapies
Infectious Diseases	Novel Antimicrobials, Vaccines, Phage Tx
Metabolic Disorders	Enzyme replacement therapies, protein therapies
Women’s Health	Microbiome-based therapeutics, long-acting contraceptives
Pediatric Medicines	Precision 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

Category	Key Documents Prepared
New Medicine	Clinical Overviews, GMP Certs, Local Labeling, Prescribing Info
Medical Devices	Technical Documentation, Product Specifications, Clinical Evaluations, IFUs
Medical Equipment	Safety Testing Data, Electrical Safety Reviews, EMT type testing
Food for Special Medical Purposes	Formulation Details, Nutritional Composition, Claims Dossiers
Disinfectant Products	Efficacy 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.

Concurrent Multi-Country Portfolio Scale-Up

Reaching 296+ million means launching in one market alone restricts collective purpose.

Our Eurasia Submissions Team eases expansion by:

Creating modular dossiers adapting to each authority
Consolidating digital tracking enabling agility as queries emerge
Harmonizing packaging artwork across markets to reduce SKU’s
Optimizing workloads preventing redundant letters of inquiry

Thus focus stays on demonstration through scientific exchange as the means but meanwhile reducing workloads.

“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:

Feasibility analysis guiding appropriate study placement
Recruitment optimization through investigator partnerships
Progress monitoring to prevent detriments to timelines
Pharmacoeconomic analysis conveying full health system impact

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

Market Pricing, Access Policy Navigation

Navigating the multi-step process to secure funding approvals after clinical validation requires addressing various access gatekeepers:

HTA submission dossier preparation conveying the clinical, economic and humanistic evidence
Payer committee representation assisting value demonstration through advisory participation
Post-assessment price-volume negotiations and conditioning strategy
Channel access advancement through provider budget steering

We ease navigation of complex multi-stakeholder processes linking patient priorities with health system purchasing policies.

Additionally our market access services span:

Due diligence support on market entry requirements
Price referencing to align with income adjusted affordability principles
Scenario modeling on access conditions bounding usage

Guiding market establishment through intimate understanding of decision drivers across government, HTA agencies and purchasing groups.

Seamless Supply Chain and Distribution Setups

Import and Export licensing
Bonded warehousing facilities connected to hospital buyers

Bridging trade compliance from plane to patient preventing product diversion.

By resolving regulatory, scientific, policy, compliance and supply facets collectively – Delta Medical helps transform conceived ideas…into localized practicality for populations relying on collaborative efforts.

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.