Alira Health

Alira Health
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Special Procedures

Assistance with Orphan, Pediatric, and Expanded/Early Access Programs

We provide comprehensive regulatory services tailored to diverse needs. For orphan drug designation (ODD), we analyze feasibility, prepare submission dossiers, and provide expert advice. Similarly, we assist in Initial Pediatric Study Plans (iPSPs), Pediatric Investigation Plans (PIPs), and Expanded/Early Access Programs, offering strategic guidance and documentation support.

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How We Help Clients

As part of our regulatory services, the Alira Health team can:
Orphan Drug Designation (ODD)
As part of our regulatory services, the Alira Health team can:
  • Analyze ODD application feasibility in the US and EU
  • Prepare FDA and EMA ODD application submission dossier
  • Prepare EMA ODD pre-submission meeting, support and attend EMA Oral Explanations
  • Provide expert advice on determining the condition prevalence
  • Prepare the FDA and EMA ODD maintenance annual report
Initial Pediatric Study Plan, Pediatric Investigation Plan (iPSP and PIP)
As part of our regulatory services, the Alira Health team can:
  • Develop the pediatric strategy adapted to your product
  • Prepare Initial Pediatric Study Plan (iPSP) Submission dossier in the US
  • Prepare Paediatric Investigation Plan (PIP) Submission dossier in the EU
  • Waiver/Deferral feasibility analysis
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:
  • Conduct EAP Feasibility Analysis for your product and the current state of the disease
  • Provide recommendations on the best EAP strategy that fits with patients’ and company’s needs
  • Assist on the documentation preparation in the most time-efficient timelines

Why Choose Us for Your Special Procedures?

  • Expertise: Benefit from our team's specialized knowledge and experience in navigating complex procedures such as Orphan Drug Designation, Pediatric Study Plans, and Expanded/Early Access Programs.
  • Tailored Support: Receive personalized assistance tailored to your product's unique needs, ensuring effective strategy development and documentation preparation.
  • Strategic Guidance: Rely on our strategic advice to maximize opportunities and streamline processes, optimizing outcomes for your regulatory goals.
 

Contact Us to Learn More About Regulatory Support for Special Procedures

 

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