Project Orbis Partner facilitates the current submission and review of oncology products which can help cancer patients access those drugs faster and easier. This collaboration between different international regulators allows patients to gain earlier access to products that have been approved by other countries’ regulatory entities.
This programme allows simultaneous dossier submission and review by different international Health Authorities, as well as speeding up patient access to innovative cancer treatments that may be more beneficial than existing therapies.
Coordinated by the FDA, it involves the regulatory authorities of Australia, Canada, Singapore, Switzerland, Brazil, Israel and UK.
What are the main advantages?
- Faster patient access to innovative cancer treatments
- Simplified simultaneous presentation of registration dossier
What can Asphalion do for you?
- Project Orbis request
- Pre-submission activities: pre-submission meetings, local regulatory requirements and Global Submission Plan (GSP)
- Dossier preparation/update
- Dossier publishing
- Support during the procedure
Have a look at the flyer here: PROJECT ORBIS PARTNER
For further information, you can send us an email at: [email protected]
