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

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