Accelerated innovation and market access is more vital than ever.
Orphan Drug Designation
At Senita, we support clients in developing drugs or biological products to prevent, diagnose, or treat a rare disease or condition by facilitating the orphan drug designation (ODD) process.
Our Services:
Determine eligibility for ODD
We assess our client’s product to determine whether it meets the eligibility criteria for ODD. This involves checking that the product meets regulatory standards.
For example, we may check:
The prevalence of the disease
The potential for the product to provide a significant impact
Whether there are other treatments for the disease
Prepare the ODD application
We help clients gather all necessary data and information, complete the required forms, and draft the necessary documents, including the Orphan Drug Designation Request. Our assessment may include the product’s intended use, mechanism of action, and potential risks and benefits.