Regulatory

Regulatory Strategies Tailored for Your Success

We Ensure Tailored Strategies, Efficient Interactions and Successful Submissions

We do this through our cross-functional team spread between the US and EU, and a large network of consultants and key opinion leaders with experience in a wide range of therapeutic areas. 

How We Help Clients

Pharma

Roadmap for regulatory and clinical strategy

Gap analysis

Due diligence

Assistance in development of combination products

Ad-hoc consulting

ODD preparation (US, EU)

Management of pediatric drug development (PIP, iPSP, RPDD, overall strategy)

 

Assistance with accelerated review program

Interactions with EU/US health authorities (FDA, EMA, national competent authorities etc)

Marketing application (MAA, NDA, BLA)

Full suite of CMC services

FDA U.S. agent for non-U.S. companies

Post-approval lifecycle management

Medtech

Strategic Support:

Roadmap for regulatory and clinical strategy

Gap analysis

Due diligence

Assistance in development of combination products

Ad-hoc consulting

US-Specific Services:

Product classification and categorization under US regulation

Pre-RFD/RFD support

513 (g)

Pre-submission meeting support

FDA submission for clearance: 510k, de-novo, EMA

Investigational device exemption IDE

EU-Specific Services:

Product classification and categorization under EU regulation (IVDR/MDR)

Notified body selection and interaction

Technical documentation preparation and submission

Post-marketing activities

Medical Device Regulation compliance (MDR)

Marie-Aude Ohresser

In the challenging environment currently redesigning regulations and incentives, it is crucial to have the right partner with strong regulatory, medical, biometric and other functions to help you to understand your new framework.”

~ Marie Aude Ohresser
Senior Vice President, Regulatory Affairs

Why Choose Us for Strategic Regulatory Support?

Addressing Common CDISC Compliance Findings for Regulatory Submission
Ainoa Forteza

At Alira Health we provide EU and US strategic and operational regulatory support for medical devices, IVDs, combination products, companion diagnostics, digital health, and more. We have a track record of over one hundred NBs/FDA direct interaction submission experience and we cover a wide range of therapeutic areas."

~ Ainoa Forteza
Vice President, Regulatory Affairs

Meet the Leadership Team

Marie-Aude Ohresser
Marie Aude Ohresser

Senior Vice President,
Regulatory Affairs
Connect on LinkedIn

Ainoa Forteza

Vice President,
Regulatory Affairs
Connect on LinkedIn

 

Contact Us to Learn More About How We Can Support Your Needs

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