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
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