Early Access Care, LLC

Early Access Care provides consultative, functional and operational support to biopharmaceutical companies for Expanded Access and Compassionate Use.. Our Mission is to accelerate access of investigational drugs to patients in need. Early Access Care provide services to (bio)pharmaceutical companies to manage requests for expanded access/compassionate use with integrity, ethics and compliance with laws. EAC manages single-patient requests (called single-patient INDs) and multi-patient expanded access protocols (EAPs). EAC provides a single point of reference for all physician inquiries to your company. EAC provides functional support across the entire request process: assisting the physician and biopharmaceutical company in managing the request and approval, tracking the request and all required elements, providing education on proper handling of the investigational drug, and verifying that the investigational drug is received by the physician. We help patients and their physicians work through the process of requesting compassionate use investigational drugs. Your internal resources are focused on drug development and not on managing compassionate use requests – this advances your filing and approval. We are experts in Expanded Access / Compassionate Use and are ready to help your company.