Infographic: The Pre-IND to Market Approval Roadmap in the U.S.
Understanding the clinical, preclinical, and technical development requirements is crucial when designing an early development pathway.
Check out our latest infographic for tips and insight into this process from the Alira Health Regulatory team.
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(...)
Alira Health Webinar Replay: Trends and Challenges in US and EU Combination Product Landscapes
Rewatch this timely webinar with Alira Health’s Regulatory leadership team featuring key insights and advice for U.S. and EU companies as they map out their own regulatory pathways(...)
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.
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(...)
Alira Health’s Ventures Portfolio Company, X-COR Therapeutics, Closes Initial $2.6M Funding Round
Alira Health congratulates X-COR Therapeutics for closing a $2.6M seed financing to continue developing its novel extracorporeal carbon dioxide removal device toward clinical trials.(...)
Reduce Time to Market with Pre-IND Meetings
Did you know reducing time to market is one of the biggest challenges companies face when seeking FDA approval on their drug development plans and clinical trials?
CMS Issues Proposed Rule to Cover ‘Breakthrough’ Medical Devices
The Centers for Medicare & Medicaid Services (CMS) issued a proposed rule this week that would give breakthrough medical devices national Medicare coverage on the same day they receive(...)