Regulatory Strategy for Emerging Biopharma

Early-stage biopharma companies face unique regulatory challenges when developing novel therapeutics. This webinar provides a strategic framework for navigating regulatory pathways efficiently while maximizing the chances of approval.

Join Michael Chen, VP of Regulatory Affairs at EloquiMed, as he shares insights gained from guiding numerous emerging biotech companies through successful regulatory submissions.

This session will cover:

• Strategic Planning: How to develop a comprehensive regulatory strategy that aligns with your development timeline and business goals.
• Special Designations: Leveraging breakthrough therapy, fast track, orphan drug, and RMAT designations to accelerate development and approval.
• Global Considerations: Strategies for approaching FDA, EMA, and other regulatory authorities with a harmonized approach.
• Pre-IND and Scientific Advice: Maximizing the value of regulatory interactions and responding effectively to agency feedback.
• Resource Optimization: How to manage regulatory documentation with limited resources while maintaining quality and compliance.

Participants will receive a regulatory strategy planning template and a decision tree for pathway selection.

This webinar is ideal for:

• C-suite executives at emerging biotech companies
• Regulatory affairs professionals in small to mid-sized organizations
• Clinical development leaders
• Project managers overseeing drug development programs
• Investors and business development professionals in the biotech space

The content is especially valuable for companies developing first-in-class therapeutics, biologics, advanced therapy medicinal products (ATMPs), and treatments for rare diseases.