[ Commercial Business Operation
[ Importing and Handling ]
[ Market Authorization Host ]
[ Expanded Access Programs ]
[ Named Patient Process (NPP) ]
[ C&MSL and Patient Support ]
& 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 LATAM, 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 to Import and Handle our client's pharmaceutical products in LATAM. We pursuit the smooth flow of samples and drugs, mitigating the risk of compromising the patient's treatment.
OrphanDC can Host Market Authorization for our clients’ products, strategically following all legal and regulatory requirements in LATAM. As a result, our clients can count on international quality standard SOPs reflected in our day-to-day operations and QA & QPPV Agreements.
OrphanDC offers an Expanded Access Program to support Patients with a pathway to innovative investigational drugs outside the clinical trial setting. The program provides the sponsor with real-world data, helping to manage risk when pre-launching the product and building relationships with both patients & the medical community.
Compassionate Use Program:
- Active Program for Oncology
& Rare Disease Patients
Patient Process (NPP)
OrphanDC provides patients and physicians in Brazil, Argentina, and Colombia the opportunity to access medicines commercially approved abroad in their own country. Named Patient Process, aka Named Patient Sale, is viable and a soft-landing chance in both territories.
Particularities in ARGENTINA:
- 3 months market access prediction
Particularities in BRAZIL:
- 6 to 9 months market access prediction
- 75% predicted market acceptance
QA Lab & Warehouse
PART OF ORPHANDC G’S HOSTING & DISTRIBUTION FACILITIES
INTERNATIONAL STANDARDS SOP IMPLEMENTATION
• QA Agreement
• QPPV Agreement
SHIPMENT, GROUND TRANSPORTATION & STORAGE
of temperature-regulated products:
• Room temperature: (+15C to +25C);
• Cold room (+2C to +8C);
• Frozen chamber (-25C to -15C).
LOGISTICS MANAGEMENT & INVENTORY