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 March 3, 2021
The 2021 MedTech Contract Manufacturing Report
Download our latest piece: The 2021 MedTech Contract Manufacturing Report. Learn how despite the ongoing pandemic, the Medical Device and CDMO industries are positioned to perform(...)
Market Access MedTech
Multimedia February 26, 2021
Pricing in MedTech: Disentangling the Roles of Payers, DRGs, and Procurement
Join host Kenny Carberry, Associate Director of Clinical Development, Dan Legg, former Director of Clinical Sourcing at Guy’s & St Thomas at the St Thomas Hospital in London and CEO(...)
MedTech Pharma
Publications February 8, 2021
Infographic: 2021 Trends in Healthcare
It is no secret that the COVID-19 pandemic has presented new challenges for businesses, and virtual has become the ‘new normal’, including for transactions.
MedTech Pharma
News February 4, 2021
2020 Year in Review
With 2021 in full swing, we want to take a moment to reflect on last year’s achievements and congratulate the entire Alira Health Team for their hard work and dedication to healthcare(...)
Regulatory
News February 2, 2021
We Secured Breakthrough Device Designation from FDA on PEDRA Xauron Perfusion System
We are proud to announce the firm’s Regulatory practice has secured a Breakthrough Device Designation from FDA for the real-time tissue perfusion system, PEDRA Xauron Perfusion System.
Clinical Regulatory
News January 7, 2021
Alira Health Adds CMC Services through Acquisition of Chamow & Associates
We have acquired Chamow & Associates (www.chamowassociates.com), a California-based integrated CMC advisory firm. This acquisition brings expertise in biologics manufacturing, quality(...)
Market Access MedTech
Publications December 5, 2020
Critical Success Factors in Market Access
Today’s MedTech market is more concentrated than ever, with critical factors that need to be examined to advance a new product.

Our locations around the globe

Welcome to Alira Health. This site is best viewed in Chrome, Microsoft Edge, or Firefox.