Learn how to create a global regulatory submission plan that streamlines your new drug registration!
Most pharmaceutical and biotech companies seek new drug approvals in both the U.S. and Europe. Historically, teams have viewed and managed the two regulatory submission processes separately.
Differences in health authority requirements, interactions, and data presentation can delay attaining regulatory approval for your drug product.
Download this Journal of Clinical Studies article and discover how to achieve a faster, smoother drug approval path.
What’s inside?
Simultaneous submissions to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) are possible! The International Council for Harmonisation (ICH) guidance facilitates the acceptance of clinical data by multiple regulatory bodies. It supports a unified submission dossier that minimizes rework, optimizes data packages, and paves the way for faster drug approvals.
Key takeaways:
- Reduced Costs: Streamline the submission process and eliminate duplicate medical writing efforts.
- Faster Approvals: Get your drug to market quicker with coordinated regulatory filings.
- Increased Efficiency: Leverage a single dossier for both regulatory authorities.
- Global Reach: Gain access to the world’s largest pharmaceutical markets.
Why Certara?
Certara’s regulatory strategy experts are committed to your drug’s success. We go beyond just achieving simultaneous approvals; we offer ongoing support throughout the drug development lifecycle, ensuring continued regulatory compliance and market access.