[ Commercial Business Operation ]
[ & Market Access Advisory ]
[ Importing and Handling ]
[ Market Authorization Host ]
& Market Access
OrphanDC’s Commercial Business Operation and Market Access area works as a patient-centric organization, with a multidisciplinary team, structured as back-office and field-work. OrphanDC operates in Brazil, and our ultimate goal is to support our clients and stakeholders with all the necessary steps related to patients’ journey up to treatment access.
OrphanDC operates with an ANVISA regulated distribution center for Importing and Handling our client's pharmaceutical products in Brazil. We pursuit the smooth flow of samples and drugs, mitigating the risk of compromising patient's treatment.
OrphanDC is able to Host Market Authorization for our clients’ products, following all legal regulatory requirements from ANVISA. Our clients can transfer their products’ market authorization anytime, and we will provide full support to stablish their own operations in Brazil.
QA Lab & Warehouse
[ PART OF ORPHANDC’S FULL HOSTING SERVICES & FACILITIES ]
SOP INTERNATIONAL STANDARDS
• QA Agreement
• QPPV Agreement (Third Party Provider)
SHIPMENT, GROUND TRANSPORTATION & STORAGE
of temperature-regulated products:
• Room temperature: (+15oC to +25oC);
• Cold room (+2oC to +8oC);
• Frozen chamber (-25oC to -15oC).
LOGISTICS MANAGEMENT & INVENTORY