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Research & Clinical Development Solutions

Regulatory Services for Pharma and MedTech

Pharma

Find out more about our Regulatory Pharma Services and expertise:

Regulatory Strategy and Due Diligence

FDA Meeting Preparation and Representation

FDA Application Preparation, Management, and Submission

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

Assistance with Accelerated Review Program

eCTD Software Platform for eCTD Submissions

CMC Quality and Regulatory Affairs

MedTech

Find out more about our Regulatory MedTech Services and expertise:

Strategy and Roadmap Development

Submission Management

FDA U.S. Agent for Non-U.S. Companies

Why choose Alira Health for regulatory support?

The Alira Health regulatory team has decades of global regulatory experience and can deliver tailored strategies, efficient submissions, and successful approvals for:

Devices
Biotech
Digital Health
Diagnostics

Global expertise in healthcare and life sciences

Regulatory approval moves your product from innovation to market, and the right regulatory strategy requires a complete understanding of the requirements that govern your market.

With our broad knowledge base and expertise, Alira Health provides full-service regulatory affairs, from strategy to submission for both medical devices (MedTech) and pharmaceutical products.

Regulatory Services that humanize healthcare

Whether you need to understand which asset best aligns with your long-term strategy, which new market or therapeutic area to explore, or how to expand into another sector, we are ready to help you lead the way.

Contact us

Giacomo Basadonna

Giacomo Basadonna, MD, PhD

Chief Medical Officer

With a full range of regulatory affairs experience in both Europe and the U.S., we guide clients to market quickly and in a cost-conscious way.

Regulatory News

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

Events September 7, 2022

MDIC Annual Patient Forum 2022

We are pleased to share that we will be joining as speakers MDIC Annual Patient Forum 2022 – a key platform for the discussion of how to transform patient engagement throughout the(...)

Clinical Trials MedTech Patient Engagement

News September 6, 2022

Alira Health Expands North American Capabilities with the Acquisition of Artisan Healthcare Consulting

The acquisition of Artisan strengthens and extends Alira Health’s Market Access and Management Consulting advisory practices in North America and globally.

Biotech Market Access Pharma Therapeutics

Events August 31, 2022

BIOMEDevice 2022

We are excited to share that we will be joining BIOMEDevice 2022 as speakers! This event will bring engineers, business leaders, disruptive companies, and innovative thinkers from the(...)

Investor Relations Medical Devices MedTech

Multimedia August 29, 2022

Webinar Replay: Clinical Trial Management in MedTech & Working with CROs

As a MedTech company, understanding clinical trial management is critical, and working with CROs is part of the journey. Join the webinar to learn about this crucial topic.

Clinical Trial Management CRO MedTech

Publications August 25, 2022

Why—and When—to Use a CDMO

Pharmaceutical development companies of all sizes frequently outsource their Active Pharmaceutical Ingredient (API) manufacturing to CDMOs for various reasons. In this article, we explore(...)

CDMO Pharma Research and Development

Events August 23, 2022

MedtechVision 2022

Join us at the MedtechWomen MedtechVision Conference, where we will be presenting a state of the Medtech Industry Report with an overview of the innovation and advancement and much more.

Diagnotics MedTech Patient Centricity