We accelerate patients' early access to rare disease therapies.
Driven by expertise, committed to improving patients' lives.
Comprehensive Depth and Breadth of Pharma Industry Experience
Years in rare diseases field
20
Therapeutic areas
17
Only one focus
Poland
Why Do We Focus Only on Poland?
Poland is:
the 5th largest country in the EU by population (38 mio) with a well-structured public healthcare system
too significant to be treated as just part of a regional CEE strategy.
requires a dedicated, local approach for your potential future presence in the country
Our Team
Over 20 years of experience in bringing rare disease therapies to the Polish market. The team has successfully led multiple reimbursement processes and commercial launches across a wide range of therapeutic areas.
We support biopharmaceutical companies at various stages of product development, offering flexible collaboration models.
Rare diseases have been our passion for many years — because they put the individual patient first. That's what resonates with us most.
How We Can Support Your Product
Before EMA Registration
We Help Shorten Time to Market by
Identifying patients and introducing early access pathways to the treatment before EMA approval and just after it.
Building a bridge between clinical trials and post-approval patient access to therapy.
Building reimbursement and pricing strategies to enter the market just after EMA approval.
Collaborating with NGOs and patient groups.
Mapping diagnostic pathways and patients' journeys.
Providing medical education to key experts and medical society.
After EMA Approval and Before National Reimbursement
Acting as the local representative of the MAH, ensuring full regulatory compliance, safety reporting, and product lifecycle management,
Executing paid early access programs to ensure patient access before reimbursement is granted
Leading the reimbursement application process, including health economic and clinical justification
Managing local pharmacovigilance and quality assurance activities in line with EU and national requirements
Establishing market operations, including warehousing, distribution, invoicing, and ongoing product availability tailored to your needs
Supporting post-launch medical and market development, including communication with authorities, clinicians, and patient organizations
After Reimbursement - Full Commercialization
Complete product commercialization and market execution
Ongoing regulatory and safety responsibilities, as local MAH representative (e.g. pharmacovigilance, quality assurance, batch release coordination)
Coordination with wholesale and distribution partners to ensure continuous product availability and EU price compliance
In-market medical support and expert engagement
Sales operations and local invoicing
Monitoring and adapting to changes in reimbursement and treatment guidelines
Ongoing cooperation with clinicians, payers, and patient organizations to support real-world uptake and patient access
At All Stages We Ensure Continuity of Therapy After Clinical Trials
Patient Need Assessment by
Identification of the number of patients requiring continued treatment post-trial.
Collaboration with clinical investigators and trial sites to estimate demand.
Clinical validation of treatment eligibility for continued access.
Transitional Access Strategies by Organizing
Product Donations - ensuring immediate post-trial access for patients in need.
Early Access Programs (EAP) - enabling treatment under managed access schemes in accordance with Polish regulations.