Emergency Use Authorization and COVID-19 Regulatory Support

Events September 28, 2023

Regulatory Roundup

Look for our clinical development experts Chris Rao and Kenny Carberry as delegates onsite at MassMedic Regulatory Roundup.

MedTech Regulatory

Publications September 22, 2023

Impact of the New EU HTA Regulation on Access to Innovative Medicines in Europe

In this interview, Alira Health Partner Chus Castillo gives updates on HTA Regulation, related challenges, and potential effect on access to innovative medicines.

Biotech Healthcare Technology Regulatory Spain

Publications August 1, 2023

The EU Pharmaceutical Package: Impact on Orphan Medicinal Products

This article reviews the proposed changes in the EU Pharma Package for data protection related to orphan medicinal products (OMPs).

EU Pharma Regulatory

Publications July 10, 2023

The EU Pharmaceutical Package: Regulatory Protection Changes

Our regulatory experts present a more detailed analysis of the proposed changes introduced to Regulatory Data Protection (RDP).

EU Pharma Regulatory

Publications June 14, 2023

Medical Device Regulation: A Checklist for Preparation

This checklist can provide you with insight into where you stand in regards to MDR preparation and what you still need to address.

Medical Devices Regulatory

Publications May 25, 2023

The EU Pharmaceutical Package: Introduction to Changes

Alira Health’s Regulatory experts explore how the proposed package will disrupt the European regulatory landscape and what it means for companies.

EU Pharma Regulatory

News February 21, 2023

Access and reimbursement pathways for digital health solutions and IVD devices

Digital therapeutics (DTx) are innovative solutions that use meaningful data to provide evidence-based decisions for the prevention, treatment, and management of diseases. Particular(...)

Diagnostics Digital Therapeutics Market Access Regulatory Research and Development