The Pre-IND to Market Approval Roadmap in the U.S.

Events May 19, 2022

DIA 2022 Global Annual Meeting

We are pleased to announce that we will be joining DIA 2022 Global Annual Meeting as exhibitors and delegates.

Biometrics Clinical Regulatory

Uncategorized April 13, 2022

U.S. and European Regulatory Strategies for Asian MedTech Startups

This webinar will focus on the U.S. FDA and EU MDR/IVDR regulatory pathways and strategies for medical device startups based in the Asia Pacific.

MedTech Regulatory

Publications April 8, 2022

Cheat Sheet: MDCG Guidance on Medical Device Classification

Assigning the proper class to a medical device (MD) is one of the most important activities carried out by a manufacturer. Read Alira Health's cheat sheet MDCG Guidance on Medical Device(...)

MedTech Regulatory

News April 5, 2022

Alira Health Strengthens Clinical Operations with the Acquisition of Sourcia

We acquired a full-service Contract Research Organization (CRO), Sourcia, that provides services for Phase I to Phase IV clinical trials with a focus on biotech, medical devices, and(...)

Clinical MedTech Patient Engagement Pharma Regulatory Research & Development

Publications March 31, 2022

The FDA’s Project Orbis Can Speed up the Delivery of Your New Oncology Drug to Global Markets

Are you developing an oncology drug? Project Orbis, a program coordinated by the U.S. Food and Drug Administration (FDA), allows you to register your product in several countries with(...)

Pharma Regulatory

Publications March 16, 2022

European Commission’s New Regulation Amending IVDR Transitional Provisions: What You Need to Know

The European Commission (EC) has published an amendment of the IVDR, delaying the transitional period for some IVDs. However, the IVDR Date of Application remains the same, so Alira(...)

Regulatory

Events July 20, 2021

Webinar Recap: Risk Management & Regulatory Submissions

Download Alira Health's Senior Vice President, Regulatory Affairs, Mary McNamara-Cullinane's webinar presentation, How to Implement Risk Management into Regulatory Submissions Using(...)