Our Expertise & Capabilities
Expertise
Pharmaceutical Development
Lucane Pharma has extensive expertise in developing medicines for small patient populations suffering from life-threatening diseases. We excel at overcoming complex formulation challenges, our specialized production capabilities are fully equiped for small-volume manufacturing, ensuring maximum batch efficiency and stable shelf life.
Clinical Development
Clinical trials for rare diseases face a unique challenge: small patient numbers make large-scale studies nearly impossible. Lucane Pharma overcomes this by designing specialized clinical programs tailored for small groups. We work closely with medical doctors to define clear, measurable clinical goals, ensuring new treatments are evaluated both safely and effectively.
Commercial
The Commercial team at Lucane Pharma supports partners in the management of hospital, insurer, and national tenders. The team provides end-to-end tender management, from opportunity identification and submission to post-tender evaluation, always keeping patient's interest at the forefront of our actions.
Regulatory Affairs & Quality
Lucane Pharma has extensive experience in obtaining and maintaining regulatory approvals for more than 100 products via CP, National, MRP, and DCP procedures. Lucane Pharma holds manufacturing and wholesale licences and is GMP- and GDP-certified by the Dutch Inspectorate, by the ANSM and the Turkish authorities. On request, the company supports EU batch release and artwork development, complaints and deviations handling, shortages and derogations and, where regulations allow, operates Named Patient Programs.
Pharmacovigilance
The pharmacovigilance department within Lucane Pharma manages a global PV system that complies with relevant country legislation and regulations world-wide. All aspect of pharmacovigilance, monitoring the benefit-risk profile of the medication and QPPV services are in-house handled responsibilities. In addition, the pharmacovigilance department can provide local pharmacovigilance services for distribution partners.
Market Access & P&R
The market access team provides comprehensive market access services, including obtaining and maintaining pricing and reimbursement. With experience across more than 180 products, the company has proven expertise in successfully navigating pricing and reimbursement procedures across a wide range of scenarios and stakeholder levels. This includes maintaining partner product records in relevant systems and implementing mandatory price updates resulting from European reference pricing.
At Lucane Pharma, we prioritize the patient, direct communication and operational speed. Contact us today to discuss your portfolio or global distribution opportunities.
