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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

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

Events February 10, 2023

Regulatory Roundup

We are pleased to announce that we are joining Regulatory Roundup as sponsors and speakers. This unique event is hosted by MassMEDIC, the largest regional medtech association in the United States.

Blog January 19, 2023

Medical Device Regulation in 2023: A Window of Opportunity

We spoke with our team of regulatory experts about the recent news regarding the MDR and the opportunity it presents to device manufacturers in 2023.

Medical Devices MedTech Regulatory

Blog January 11, 2023

Regulatory Strategy for Registering Rare Disease Products in the EU: What You Need to Know

Given that the regulation is likely to change considerably, drug developers may need to revisit their development strategy. In the meantime, building a strategy around these evergreen(...)

EU Rare Disease Regulatory

Blog December 21, 2022

2022 Recap: Your Favorite Alira Health Publications

In 2022, the Alira Health team of scientists, strategists, economists, clinicians, and biostatisticians shared actionable insights, industry thought leadership, and leading-edge guidance(...)

Clinical Digital Health Market Access MedTech Pharma Regulatory

Multimedia December 17, 2022

Webinar Replay: Partnering with Patients to Streamline Trial Operations: Protocol to Regulatory Submission in 60 days

Learn how patients and patient advocacy organizations can be directly enabled as powerful partners to facilitate all stages of DCT deployment, from protocol design, recruitment, engagement(...)

Clinical Trials Patient Centricity Regulatory