- 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.
Regulatory: Pharma
Special procedures
(Orphan, Pediatric, Expanded/Early Access Program)
- 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.
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:- 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.