Research and Clinical Development Solutions
From Regulatory Strategy to Submission and Beyond,
Alira Health Supports Global Product Development
Regulatory approval moves your product from innovation to market. Defining a regulatory strategy that maps your journey through the approval process is critical but understanding the regulatory requirements that govern your market takes a broad knowledge base and a wide range of expertise.
Alira Health is a full-service regulatory partner with decades of global regulatory experience, thanks to a cross- functional team spread between the US and EU, and a large network of consultants and KOLs to ensure tailored strategies, efficient submissions, and successful approvals.
Why Choose Alira Health for Regulatory?The Alira Health regulatory team has decades of global regulatory experience and can deliver tailored strategies, efficient submissions, and successful approvals for devices, biotech, digital health, and diagnostics. Our wide-ranging expertise across therapeutic areas include:
In this interview, Alira Health Partner Chus Castillo gives updates on HTA Regulation, related challenges, and potential effect on access to innovative medicines.
This article reviews the proposed changes in the EU Pharma Package for data protection related to orphan medicinal products (OMPs).