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