Regulatory: MedTech

Strategy and Roadmap Development

Delivering sound strategies and executable roadmaps

The Alira Health takes a holistic view in creating your regulatory strategy and plan. Our regulatory experts, doctors, scientists, and strategists work together to deliver tailored solutions that meet both regulatory requirements and your business objectives.

A focus on efficiency

Our strategies are designed to help you balance risk, increase speed, and decrease costs associated with:
  • Aligning regulatory strategy with client marketing claims, indications for use and business objectives
  • Orphan designations
  • Breakthrough designations
  • Fast track designations
  • Adaptive design programs
  • Direct-to-patient programs
  • Hybrid programs
  • PRIME programs

Why choose Alira Health?

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

Related news

Blog November 22, 2023
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Discover the notable trends in the diabetes management devices market including glucose monitoring, insulin delivery and digital health.
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Misconceptions About Patient-Centric Co-Design
Many people have misconceptions about patient-centric co-design, and these misconceptions are holding companies back.
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Multimedia October 24, 2023
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Kenny Carberry, VP, Business Development, Research & Clinical Development, joins the “Clinical Trials & Hospital Pilots” webinar as speaker.
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Publications October 17, 2023
Trends and Challenges in Diabetes Management Devices
Our experts had a look at the Diabetes Management Devices Market and identified the current regulatory and market access trends and challenges in this PM360 article.
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Blog October 16, 2023
How to Co-Design a Solution with Patients to Meet Their Needs
To learn how you can benefit from a co-design approach and how to get started, we spoke with two experts on patient engagement and co-design.
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Blog October 16, 2023
Macro Market Trends Impacting Cardiology Medical Devices
This article describes four key macro trends as outlined in our report, Cardiology Medical Devices Market Trends 2023.
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Events October 15, 2023
Virtual Startup Demo Day
Join us and hear pitches from the leading startups in New England and beyond at the MassMedic Startup Virtual Demo Day.
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