Alira Health

Alira Health

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

Reports May 20, 2024
Innovative Payment Schemes for Medtech in England, Germany, and France
This overview offers high-level details on the innovative payment schemes in England, Germany, and France.
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Case Studies May 14, 2024
Medtech Company Creates an Early Go-to-Market Strategy for Its Breakthrough IVD Solution
The client needed an early go-to-market strategy for their IVD solution to prepare for product development and launch in key European countries and the US.
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Case Studies May 8, 2024
Mid-Size Medtech Company with a Borderline Product Defines Strategy for EU Launch
Medtech company sought support in developing a regulatory strategy for the EU launch of their product with an aggressive timeline to launch.
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Reports May 8, 2024
Value-Based Procurement in Australia
This white paper discusses why value-based healthcare and procurement are solutions in a robust healthcare system and identifies the medical technology sector as a collaborative partner(...)
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Case Studies April 30, 2024
Medtech Company Leverages Bayesian Clinical Trial Design to Address FDA Feedback
A global medtech company needed help to address FDA feedback on their implant design that included a comparator and clearly demonstrated the safety and performance of this new device.
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Events April 30, 2024
The MedTech Forum 2024
We are thrilled to announce that we will exhibit and speak at The MedTech Forum 2024.
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News April 29, 2024
Alira Health Advises Trill Impact Entering a Strategic Alliance with TT medic
We are pleased to have been a Commercial Due Diligence advisor for Trill Impact, a pioneering Impact House with around EUR 1.2 billion in assets under management, joining forces with(...)
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