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Regulatory: Pharma

eCTD Submissions and Software Platform

Our eCTD services: software support

As part of our regulatory services in pharma, the Alira Health team can publish electronic common technical documents, validate, and compile submissions and submit them via electronic submissions gateway to the FDA.

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

Explore Regulatory Pharma Services:

Regulatory Strategy and Due Diligence

FDA Meeting Preparation and Representation

FDA Applications Preparation, Management, and Submissions

CMC, Non-clinical, Clinical, and PK Program Support

Assistance with Accelerated Review Programs

CMC Quality and Regulatory Affairs

eCTD Submissions - News

News October 4, 2022

Alira Health enhances its market access services through a strategic partnership with Centivis

Alira Health, a global healthcare advisory and technology company, announced a strategic partnership with Centivis AG, a boutique market access consulting agency, specializing in digital(...)

Digital Health Market Access MedTech Pharma Regulatory

Multimedia September 29, 2022

Regulatory Strategy for Registering Rare Disease Products in the EU

In this webinar we will focus on how to benefit, today and in the future, from the orphan drug program and build a regulatory strategy for successful rare disease product registration(...)

Drug Development Rare Disease Regulatory

Publications August 4, 2022

White Paper: New European Health Technology Assessment Regulation

In this white paper, we provide an overview of this new regulation, including key points of the new European Health Technology Assessment Regulation, its methodology, and its timelines.

MedTech Regulatory

Publications July 15, 2022

How to leverage registry-based studies to generate high-quality Real-World Evidence

The use of Real-World Evidence (RWE) in regulatory decision making will support the development and application of better medicines.

Real-World Evidence Registry-based studies Regulatory RWE

Publications July 14, 2022

How to successfully use the EMA IRIS portal to ensure timely submissions

Submitting your scientific advice (SA), orphan drug designation (ODD) or Innovation Task Force (ITF) consultation to the EMA? Avoid delays with our submission recommendations.

European Medicines Agency Orphan Drug Regulatory

Multimedia July 12, 2022

Webinar Replay: What You Should Know About MDR Best Practices, Including PMCF

Discover the major changes introduced by the MDR, including the post-market requirements, and especially the Post-Market Clinical Follow-up (PMCF).

MedTech Regulatory

Events June 30, 2022

DTx France 2022

We are pleased to announce that we will be joining as speakers and exhibitors at DTx France 2022. This hybrid event will focus on the latest DTx trends, regulatory framework, market(...)

DTx trends Market Access Regulatory