Summary
As the FDA rolls out ESG NextGen to modernize how it securely receives and processes electronic submissions, including new options such as a web-based Unified Submission Portal (USP), API-based submissions, and AS2 connectivity, regulatory teams need submission operations that can keep up.
In this webinar, you’ll see how Certara’s GlobalSubmit™ helps you capitalize on ESG NextGen by streamlining the work before you hit “send”: publishing submission-ready eCTD content, running robust validation to catch compliance issues early, and enabling efficient, collaborative review so your packages are ready for transmission via ESG NextGen’s USP/API/AS2 pathways.
Top 3 learnings from the ESG NextGen webinar overview
- How ESG NextGen is redefining FDA submissions with faster, smarter, more secure pathways.
- How to future-proof regulatory operations with upgraded processes designed for ESG NextGen speed.
- How GlobalSubmit enables teams to deliver eCTD-ready, fully validated submissions, for seamless ESG NextGen transmission.
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Somya Agarwal
Product OwnerSomya Agarwal is a Product Owner who has spent the last 15 years working on life sciences software development with a focus on eCTD technology. She is a customer-focused professional with expertise in the areas of Quality and Validation Management, SDLC Management, requirement gathering, and UI/UX design. In addition to Somya’s extensive software experience, she has worked with numerous health authorities to help define, build, and implement solutions that assist in the overall submission process.
Somya has held positions at Certara, Synchrogenix, and HCL Technologies where she has demonstrated strong leadership skills and taken various technology initiatives to completion.
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