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Learning Center

Navigating the regulatory pathway from discovery to the clinic for CRISPR-based therapeutics is a complex and multifaceted process. It is not only driven by technical advancements, but also necessitates a concerted effort that marries regulatory insight with ongoing dialogue with regulatory bodies. Join our series of regulatory insights where we will guide you through the intricate regulatory voyage of cell and gene therapies (CGTs) and optimize your pathway to success.

From Concept to Clinic: Navigating the Regulatory Path of CRISPR-based Therapeutics

Navigating the regulatory pathway from discovery to the clinic for CRISPR-based therapeutics is a complex and multifaceted process.

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Ensuring Quality and Compliance: CMC Strategy for CRISPR-based Therapeutics

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Ensuring Translational Success: Preclinical Study Design for CRISPR-based Therapeutics

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Whitepaper Highlights:

From Concept to Clinic: Navigating the Regulatory Path of CRISPR-based Therapeutics Ensuring Quality and Compliance: CMC Strategy for CRISPR-based Therapeutics Ensuring Translational Success: Preclinical Study Design for CRISPR-based Therapeutics
  • Key regulatory milestones in the CGT drug development process
  • Key considerations in each phase, including supporting guidelines and resources
  • IND filing, FDA review and approval process explained
  • Explore the critical role of CMC Strategy in ensuring the safety, quality, and efficacy of CRISPR-based therapies
  • Regulatory frameworks and CMC requirements explained
  • Benefits of phase-appropriate CMC development
  • Understand the importance of strategic preclinical study design in the path to IND approval
  • Explore key aspects of pharmacology and toxicology testing
  • Learn about common causes of preclinical study failure and how to avoid them

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