Alira Health

Alira Health

Regulatory: Pharma

eCTD Submissions and Software Platform

Why choose Alira Health for eCTD Submissions?

As your partner, Alira Health supports your innovation, optimizing product development success every step of the way. Our integrated, collaborative teams provide a lifecycle approach to delivering our services, including:

  • Regulatory strategy
  • Regulatory intelligence
  • Regulatory operations
  • Clinical
  • Market access

eCTD Submissions - News

Case Studies May 8, 2024
Mid-Size Medtech Company with a Borderline Product Defines Strategy for EU Launch
Medtech company sought support in developing a regulatory strategy for the EU launch of their product with an aggressive timeline to launch.
Medical Devices MedTech Regulatory
Events April 30, 2024
The MedTech Forum 2024
We are thrilled to announce that we will exhibit and speak at The MedTech Forum 2024.
MedTech Regulatory
Articles April 17, 2024
The Challenges for Medtech in a Complex Regulatory Landscape in 2024
Learn more about what manufacturers in the US and Europe should consider when developing their regulatory strategies and prioritizing their target markets from regulatory affairs expert Mercè Guerra.
Medical Devices MedTech Regulatory
Events February 21, 2024
XXII Conferenza Nazionale Sulla Farmaceutica
Meet Giovanni Firenze, Partner Consulting Italy, onsite in Catania and learn more about the impact of the new AIFA reform.
Italy Regulatory
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
Reports 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
Reports 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
Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.