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

MedTech
Events October 12, 2021
Event: HLTH Conference
Join Aude Ouensanga and Deepak Sahu at HLTH in Boston, MA.
MedTech
Publications September 27, 2021
A Robotic-Assisted Surgery (RAS) Review: Clinical Landscape, Commercial Arena, and Future Outlook
Today’s $7B global Robotics-Assisted Surgery (RAS) market is projected grow to $30B in 2030. Download Alira Health’s Full RAS report to understand adoption dynamics today – technologies,(...)
MedTech
Multimedia August 6, 2021
Alira Health’s Transformation Talks: Overcoming Challenges to Reimbursement in Robotic Surgery for the French Market
Our latest Alira Health Transformation Talks is all about Robotic Surgery.
MedTech
Events August 5, 2021
Event: The MedTech Conference
Join the Alira Health team at AdvaMed September 29-30, 2021 in Minneapolis, MN.
MedTech
News July 27, 2021
Alira Health Announces it Role as Strategic Advisor to Montagu Private Equity
We are pleased to have advised Montagu PE in the acquisition of Intech, a target active in the design and manufacturing of complex reusable surgical instrumentation for Minimal Invasive(...)
MedTech
News July 22, 2021
Alira Health Welcomes Fredrik Nyberg as Partner and Regional Head
We are pleased to announce that Fredrik Nyberg has joined Alira Health as Partner and Regional Head
Regulatory
Events July 20, 2021
Webinar Recap: Risk Management & Regulatory Submissions
Download Alira Health's Senior Vice President, Regulatory Affairs, Mary McNamara-Cullinane's webinar presentation, How to Implement Risk Management into Regulatory Submissions Using(...)

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