Regulatory: Pharma

CMC Regulatory Affairs and Quality Management

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 processes and CMC regulatory affairs. 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 for your CMC Regulatory Affairs?

Our global team has significant industry experience providing guidance to meet evolving global CMC 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 CMC Regulatory News

Publications August 1, 2023
The EU Pharmaceutical Package: Impact on Orphan Medicinal Products
This article reviews the proposed changes in the EU Pharma Package for data protection related to orphan medicinal products (OMPs).
EU Pharma Regulatory
Publications July 10, 2023
The EU Pharmaceutical Package: Regulatory Protection Changes
Our regulatory experts present a more detailed analysis of the proposed changes introduced to Regulatory Data Protection (RDP).
EU Pharma Regulatory
Publications June 14, 2023
Medical Device Regulation: A Checklist for Preparation
This checklist can provide you with insight into where you stand in regards to MDR preparation and what you still need to address.
Medical Devices Regulatory
Publications May 25, 2023
The EU Pharmaceutical Package: Introduction to Changes
Alira Health’s Regulatory experts explore how the proposed package will disrupt the European regulatory landscape and what it means for companies.
EU Pharma Regulatory
News February 21, 2023
Access and reimbursement pathways for digital health solutions and IVD devices
Digital therapeutics (DTx) are innovative solutions that use meaningful data to provide evidence-based decisions for the prevention, treatment, and management of diseases. Particular(...)
Diagnostics Digital Therapeutics Market Access Regulatory Research and Development
Events February 10, 2023
Regulatory Roundup
We are pleased to announce that we are joining Regulatory Roundup as sponsors and speakers. This unique event is hosted by MassMEDIC, the largest regional medtech association in the United States.
Regulatory
Blog January 19, 2023
Medical Device Regulation in 2023: A Window of Opportunity
We spoke with our team of regulatory experts about the recent news regarding the MDR and the opportunity it presents to device manufacturers in 2023.
Medical Devices MedTech Regulatory
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