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
XXII Conferenza Nazionale Sulla Farmaceutica
Meet Giovanni Firenze, Partner Consulting Italy, onsite in Catania and learn more about the impact of the new AIFA reform.
Look for our clinical development experts Chris Rao and Kenny Carberry as delegates onsite at MassMedic Regulatory Roundup.
Impact of the New EU HTA Regulation on Access to Innovative Medicines in Europe
In this interview, Alira Health Partner Chus Castillo gives updates on HTA Regulation, related challenges, and potential effect on access to innovative medicines.
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).
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).
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.
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.