Regulatory: Pharma

FDA Applications Preparation, Management, and Submissions

Our services: FDA Applications

As part of our regulatory services in pharma, the Alira Health team can:
  • Assist with authoring IND, NDA, BLA for both 505 (b)(1) and 505(b)(2) pathways in addition to ANDA applications
  • Serve as the project manager for regulatory submissions, and plan, track, collect, review, and finalize the documents for various modules in an FDA submission as per the eCTD guidelines
  • Act as a U.S. agent for FDA Submissions for firms located outside the U.S.

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

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(...)
Advanced Analytics Regulatory Research & Development
News November 20, 2020
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.(...)
Regulatory
Publications November 1, 2020
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?
MedTech Regulatory
Publications August 11, 2020
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(...)
Pharma Regulatory
News July 9, 2020
We Welcome Olga Carroll, PhD as Vice President, Global Regulatory Affairs
We are pleased to announce that Olga Carroll, Ph.D. joined the firm as Vice President of Regulatory.
Regulatory
Publications May 20, 2020
Emergency Use Authorization and COVID-19 Regulatory Support
The Alira Health Regulatory team has worked closely with our industry partners and the FDA during the COVID-19 pandemic, helping to bring critical products to market through the Emergency(...)

Our locations around the globe

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