What Makes Us Different? Our Expertise / Core Competencies

Delivering structured, compliant, and efficient market entry solutions for pharmaceutical and biotech companies.

At NEXA Pharm, we provide end-to-end expertise that enables international pharmaceutical and biotechnology manufacturers to navigate the regulatory, pricing, and market-access landscape of Azerbaijan with clarity and confidence. Our competencies are built on deep industry experience, strong knowledge of local legislation, and a strategic understanding of how innovative therapies can successfully enter the market.

Why Our Expertise Matters

Entering a new market requires more than regulatory submissions — it demands strategic insight, rigorous compliance, and deep knowledge of local healthcare dynamics.
NEXA Pharm brings these capabilities together, offering manufacturers a reliable partner who can navigate complexity, minimize risk, and accelerate success in Azerbaijan.

Below is an overview of our core strengths that form the foundation of our services:

  • We build tailored regulatory roadmaps that reflect product type, therapeutic area, and applicable regulatory pathways.
    Our capabilities include:

    • Evaluation of eligibility for national or recognition procedures

    • Gap analysis of CTD / eCTD dossiers

    • Alignment with MoH and AEC requirements

    • Strategic preparation of administrative, quality, non-clinical, and clinical modules

    • Lifecycle management: variations, renewals, labeling updates

    Our approach ensures that dossiers are fully aligned with regulatory expectations, reducing delays and improving submission quality.

  • Azerbaijan operates a strict reference-pricing system, where accuracy and strategic planning are critical.
    We offer:

    • Comprehensive reference-country price mapping

    • Calculation of expected ex-factory and retail prices

    • Preparation of pricing submission packages in line with Tariff Council requirements

    • Assessment of future price updates and indexation scenarios

    • Advisory on optimal launch sequencing for sustainable pricing

    Our expertise helps manufacturers achieve transparent and compliant pricing while protecting product value in the long term.

     

  • Specialty medicines require a unique market approach due to clinical complexity, small patient populations, and procurement mechanisms.
    NEXA Pharm supports companies with:

    • Identification of unmet medical needs and patient pathways

    • Evidence-based value proposition development

    • Engagement strategy for key clinical experts

    • Access planning for hospital, retail, and national procurement channels

    We create access strategies that ensure early understanding and long-term adoption of high-value therapies.

  • We manage full preparation of documentation for regulatory and pricing approval:

    • Regulatory dossier submission and tracking

    • Pricing applications

    • Close communication with MoH, AEC, Tariff Council, and related bodies

    • Preparation of additional clarifications and responses to queries

    Our structured process minimizes administrative risks and supports timely decision-making by authorities.

  • For many therapeutic areas in Azerbaijan, tenders and hospital channels represent the core access route.
    We help companies to:

    • Assess tender eligibility and requirements

    • Prepare all necessary procurement documentation

    • Develop hospital access positioning and value messaging

    • Identify distribution models compliant with local procurement rules

    These capabilities enable manufacturers to compete effectively in the national procurement environment.

     

  • Before entering the market, companies need clear data to inform decisions.
    We provide:

    • Market size analysis and demand forecasting

    • Competitor benchmarking

    • Epidemiology and public-health insights

    • Product-specific feasibility analysis

    • Local healthcare system mapping

    This insight reduces risks and ensures informed planning for commercial success.

  • We operate under strict compliance principles aligned with international and local standards.
    Our practices include:

    • Ethical interactions with healthcare professionals

    • Compliance with promotion and advertising rules

    • Transparent communication in scientific and commercial activities

    • Data protection and confidentiality adherence

    • Internal quality controls across all processes

    Our commitment to ethics ensures long-term trust and sustainable partnerships.

Expert in healthcare, pharmaceutical market of Azerbaijan