PSR is the leading expert in orphan drug development. We assist our clients to design and execute successful clinical development strategies for orphan indications. We are specialized in complex development clinical programs requiring innovative regulatory and clinical approaches.
PSR has a strong track record in supporting orphan drug applications and we can facilitate obtaining scientific advice and protocol assistance at EMA and FDA level.
We can help our clients identify products that potentially qualify for an orphan drug status.
The World Orphan Drug Congress is a multi-faceted event
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