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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

Explore CMC Services:

CMC Manufacturing Strategy and Operations

CMC Process Development and Optimization

CMC Outsourcing Support

CMC GMP Facility Design

CMC Project Integration

CMC Technical and GMP Training

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