focused
Early Access Programs
Comprehensive market access and regulatory support in pharmaceutical early access programs. Unlock strategic insights for effective navigation of Ukraine's regulatory landscape.
Supporting Early Access Programs in Ukraine, CEE, and beyond
Target industries: Pharmaceuticals/ Biopharmaceuticals
Case studies:
The Eirhub team offers various support to pharma and biopharma companies in Ukraine, CEE, Central Asia, and the South Caucasian countries, including:
- COMPREHENSIVE REGULATORY ANALYSIS—A thorough analysis of the regulatory framework governing early and extended access programs. This includes reviewing existing regulations, guidelines, and requirements to ensure compliance.
- STAKEHOLDER MAPPING—Identifying and mapping all relevant stakeholders involved in early access programs, including regulatory authorities, ethics committees, patient advocacy groups, healthcare providers, and pharmaceutical companies.
- COMPETITIVE TREATMENT OPTIONS ANALYSIS—A detailed analysis of registered competitive treatment options in Ukraine. This includes assessing the efficacy, safety, and pricing of these treatments.
- ANALYTICAL REPORT ON TARGET INDICATIONS—An analytical report focused on the target patient populations for specific indications. Such a report would include information on disease prevalence, demographics, and unmet medical needs.
- PRICING ANALYSIS—Analyzing the price parameters of available treatment methods in Ukraine is essential to understanding the economic aspects of early access programs. This information can be valuable for possible future pricing and reimbursement strategies.
- IDENTIFYING TARGET MEDICAL INFRASTRUCTURE—Identifying healthcare institutions and treating physicians willing to participate in early access programs for specific indications. Assessing their readiness and willingness to participate in early access programs.
- RECOMMENDATIONS and COMMUNICATION PLAN—Formulating recommendations for decision-makers and developing a comprehensive communication plan. This plan will address the needs and expectations of each stakeholder group, including HCPs, patient advocacy groups, payors, authorities, and distributors.

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