Regulatory: Pharma

CMC Quality and Regulatory Affairs

Rely on an experienced quality and regulatory support team

Alira Health CMC fully understands the complex regulatory challenges of drug development and provides in-depth guidance across all quality and regulatory processes. We can:
  • Design quality management systems, including the creation of SOPs and execution of vendor audits
  • Lead and participate in global regulatory interactions
  • Create and recommend regulatory strategies
  • Generate responses to agency requests, comments, and questions
  • Author and maintain global regulatory dossiers
  • Generate and maintain Quality Agreements
  • Engage authors to prepare pre-IND briefing package and CMC section of IND/IMPD/BLA

Why choose Alira Health?

Our global team has significant industry experience providing guidance to meet evolving global regulatory guidelines. Our dedicated team provides:

  • Strong, in-depth knowledge of quality processes and compliance across all stages of biotherapeutic development
  • Excellence in drafting and negotiating quality agreements
  • High volume experience in global regulatory submissions and documentation, including generation and modification

Related news

Regulatory
Events April 29, 2021
Alira Health Webinar: 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(...)
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.

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