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
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(...)
Regulatory
Publications July 20, 2021
Infographic: The Pre-IND to Market Approval Roadmap in the U.S.
Download our latest infographic, The Pre-IND to Market Approval Roadmap in the U.S.
MedTech
Events July 15, 2021
Event: Cardio Wearables 2021 Conference
Join Piergiulio Lauriano for an exclusive discussion on Cardio Wearables Investments and M&A Trends during the conference.
MedTech Pharma
Events June 30, 2021
Event: Bio Asia-Taiwan
Join Daniela Sica, Vice President, Business Development, Pharma & Biotech, and Shu-Ling Cheng, Partner, at Biotechnology Innovation Organization's Bio-Asia Taiwan July 21-25, 2021.
MedTech
Publications June 2, 2021
Infographic: U.S. Go-to- Market Strategy Design for Wearable Technology in Healthcare
When our client, a European healthcare-based startup developing wrist wearables wanted to expand to the U.S., the Alira Health team helped develop a go-to-market strategy for this new segment.
MedTech
Publications May 14, 2021
Pocket Guide To MedTech’s Market Outlook In 2021
In this article Carlo unveils findings and summaries from The 2021 MedTech Contract Manufacturing Report, recently published by Alira Health in collaboration with Life Science Intelligence(...)

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