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

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