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

Publications June 23, 2022
Developing Data Specialist Talent: Collaboration Is Key
Companies across Pharma and MedTech need talented people to cover the range of data-related challenges. Discover what this means for developing talent throughout the industry.
Data Specialist MedTech Pharma
Multimedia June 21, 2022
Increasing Access to Genomic Testing in Europe
Listen to the episode “Increasing Access to Genomic Testing in Europe: The role of national genomic initiatives in increasing uptake of Advanced Diagnostics”.
Genomic Testing Market Access MedTech
Publications May 27, 2022
The Impact of Chip Shortage on the MedTech Sector and RAS Players
Discover the three factors driving the chip shortage, the impact, and what’s next for Robotic and MedTech industry at large.
CDMO MedTech Robotcs
Events May 19, 2022
DIA 2022 Global Annual Meeting
We are pleased to announce that we will be joining DIA 2022 Global Annual Meeting as exhibitors and delegates.
Biometrics Clinical Life Sciences Regulatory
News May 11, 2022
Alira Health Acquires RedCrow, an Equity Crowdfunding Platform for Healthcare Startups
We acquired RedCrow, an alternative investment platform that provides individual investors with easy access to expert-vetted healthcare start-ups. The financial terms of the transaction(...)
MedTech Patient Engagement Pharma
Events May 9, 2022
7e Journée start-up innovantes du dispositif médical
Clinical Digital Health Market Access MedTech Research & Development
Multimedia April 13, 2022
U.S. and European Regulatory Strategies for Asian MedTech Startups
This webinar will focus on the U.S. FDA and EU MDR/IVDR regulatory pathways and strategies for medical device startups based in the Asia Pacific.
MedTech Regulatory
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