Partnering with pharmaceutical and biotechnology companies
Demand for medicines has never been greater, yet the path to market is uncertain and it takes years to get new therapies licensed and available to patients. Today, requests for access to pharmaceutical and biotechnology products often begins well before therapies are commercially available. Access to information on possible treatments is easily available via the web, which enables patients and their families to research possible treatments, keeping them up-to-date on any new therapies in development.
Patients who have exhausted all other avenues of treatment and who do not qualify for participation/continued participation in clinical trials are seeking access to these promising therapies — and often cannot afford to wait.
How can pharmaceutical and biotechnology companies manage patient requests for treatment, which, if communication is not properly channeled, can result in negative publicity? How can they fulfill their obligation to provide ethical access, while remaining compliant? Caligor provides the answers to these questions effectively filling the access gap.
An expert team to manage critical programs.
Caligor has the experience, the means and the tools to develop and implement global programs that bridge the gap between innovation and commercial availability for life-saving and life-changing medicines. By choosing Caligor as your access partner, you achieve ethical access in a compliant, controlled, and legal way while removing the resource burden of managing these programs from your team.
Once your program is established with Caligor, we will be the point of contact for patient and physician requests, ensuring adherence to all program specifications, continuously monitoring the regulatory landscape, and proactively working with you should any changes in regulations have an impact on your program. We will handle all day-to-day operations, and provide you with the detailed reporting that you, as the GAP sponsor, require and expect.
Working alongside your team, we provide strategies to allow access throughout the product life cycle. Planning for, and establishing a GAP with Caligor early in the product development cycle offers manufacturers the ability to anticipate and meet early demand, gain valuable insight on “real world” use, and provide access to products throughout their life cycle.
A trusted partner to design, implement and manage your GAP.
Caligor will work with you to provide individual access solutions to meet patient needs. We offer:
Regulatory expertise – Our in-depth regulatory knowledge enables us to navigate the complexities of compassionate use/ethical access laws and regulations that are specific to each country to ensure program compliance.
Global reach – Our international distribution and logistics capabilities allow us to reliably meet patient demands throughout the Americas, Europe, and Asia, extending your market reach.
Personalized attention – As a Caligor GAP partner, you enjoy highly attentive service at every step — from planning your access strategy, to comprehensive program development utilizing our GAP Compass, to implementation and day-to-day operations and logistics. We handle all the details to make providing ethical access easy and cost-effective for your organization.
Peace of mind – Our team is committed to managing your program with a keen focus on quality, honesty, integrity, and strict adherence to all regulatory and legal requirements.
A relationship-focused approach – Our team understands the critical importance of strong and effective relationships serving as the foundation for success. This is reflected in how we represent you through our relationships with your treating physicians, and all internal/external stakeholders for the program. Our authenticity and honest approach can be seen and felt across all areas of our business.
Caligor will plan, develop, and implement your GAP strategy to help your organization make a positive impact on the lives of patients, while expanding your market footprint on a global scale.
To learn how a GAP partnership could benefit you, please contact us today.