Home > Our Services > Regulatory

Research & Clinical Development Solutions

Regulatory Services

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

Medical Device Regulation (MDR)

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 May 26, 2023

Webinar on Advancing Patient Engagement in the Medical Device / MedTech Industry

Engaging with patients, including their caregivers and advocates, is crucial during the planning and execution of clinical trials.

Medical Devices MedTech Patient Engagement

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

Blog May 17, 2023

Introduction to Patient Engagement in MedTech in the U.S.

Check out these key takeaways from our Playbook for Patient Engagement in MedTech in the U.S. and access the playbook download.

MedTech Patient Engagement USA

Events May 16, 2023

PSI 2023 Conference

We're excited to talk orphan drugs and rare diseases at the World Orphan Drug Congress in Washington, D.C.

Orphan Drug Pharma Rare Disease UK

Events May 15, 2023

World Orphan Drug Congress USA

We're excited to talk orphan drugs and rare diseases at the World Orphan Drug Congress in Washington, D.C.

Orphan Drug Pharma Rare Disease

Events May 15, 2023

BIO International Convention

We are excited to share that we will be attending the BIO International Convention in Boston. This leading industry event attracts biotechnology and pharma leaders for one week of intensive(...)

Events April 26, 2023

MedTech Forum 2023

We are excited to share that we will be sponsoring and speaking at MedTech Forum 2023. The MedTech Forum is the largest health and medical technology industry conference in Europe and(...)

MedTech Real-World Evidence (RWE)