CMC Quality and Regulatory Affairs
Rely on an experienced quality and regulatory support team
- 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 team has more than a decade of experience guiding companies through biologics development.
As our partner, you’ll benefit from:
- Comprehensive, integrated CMC services that deliver holistic solutions tailored to your business needs and goals
- Knowledgeable industry leaders who deliver scalable, actionable insights
- Close collaboration and clear communication from engagement to launch