Alira Health

Alira Health

Regulatory: Pharma

Special procedures
(Orphan, Pediatric, Expanded/Early Access Program)

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Orphan Drug Designation (ODD)

 

Our Services: Orphan Drug Designation (ODD)

As part of our regulatory services, the Alira Health team can:

Our Services: Initial Pediatric Study Plan, Pediatric Investigation Plan (iPSP and PIP)

As part of our regulatory services, the Alira Health team can:
 

Our Services: Expanded/Early Access Program

EAPs are national schemes that allow pre-approval access to medicines under physician’s responsibility, for certain patients with life threatening diseases having no treatment options available. EAPs may serve as well to fill the gap between drug approval and commercialization. As part of our regulatory services, Alira Health team can:

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