Early and Expanded Access to Treatment and Unlicensed Medicine Programs
Fast, Efficient Solutions
Reach out to us to embark on a journey of innovation and achievement.
Empowering Patient Access: Unleash the Potential of your product using Early and Expanded Treatment Programs
We believe that every patient deserves timely access to life-changing treatments. Our Early and Expanded Access to Treatment and Unlicensed Medicine Programs bridge the gap between clinical development and commercialization, offering hope to patients with unmet needs. Alexavi are pioneers and innovators in this area. We have designed and implemented numerous unique and novel programs to meet the needs of patients and clients
Early Access:
Bridging the Gap:
- Closing the Gap: Early access programs address the needs of patients who are waiting for commercialization while battling unmet conditions.
- Physician Interest: When clinical studies showcase safety and efficacy, physicians seek opportunities to offer promising treatments to eligible patients.
- Real-World Evidence: Our programs facilitate real-world data collection, supporting regulatory submissions and fostering early adoption by physicians.
- Minimal cost: Many programs offering advanced access, such as Named Patient Programs, allow for recovery of some fo the costs, reducing the financial burden to you
- Named Patient Programs: Let us help you get your product to those who need it, in regions where full commercialisation isn’t planned. We can support physicians help them obtain medical products for their patients for products not currently available in their local region. These paid programs provide the opportunity for you to test a market before entering.
Our Expertise:
- Tailored Programs: We specialise in designing comprehensive Treatment Management Programs, encompassing both drugs and devices. We work with national and local authories at all levels to ensure that those who need it most are getting the treatments they require.
- Specialised Therapies: Our expertise extends to specialised therapies, including biologics, , and controlled drug substances.
Our Services:
- Strategic Design: We craft programs that address unmet needs, empowering early and expanded access. We design bespoke programs, not the typical standard “check the box” approach
- Regulatory Expertise: Navigate regulatory landscapes with precision, ensuring compliance and swift access as we work with agencies and authorities at all levels to bring success to patients and to the local communities
- Holistic Management: From project to financial oversight, we handle all aspects to ensure seamless execution and program success
- Physician Engagement: Engage and support physicians, ensuring seamless program integration.
- Logistics Excellence: We help you manage secondary packaging, labelling, storage, and distribution through a network of partner and supplier GMP facilities.
- Real-World Data: Collect and evaluate real-world data to assess financial impact and position HEOR analyses support approvals and help embattled health systems to realise the benefits
Alexavi Healthcare
Why Choose Us:
- Patient-Centric Approach: We’re dedicated to improving patient lives, guiding programs that make a meaningful impact to patients and your programs
- Pioneering Solutions: Our expertise allows us to navigate complex challenges, delivering innovative solutions, We are not the “vanilla” solutions provider.
- Global Expertise: From regulatory nuances to logistics, our global expertise ensures successful program implementation.
- Proven Results: Join a growing number of clients who have seen faster adoption, improved clinical interest, and improved pricing.