eCTD Publishing & Submission Management
Global’s dedicated eCTD publishing team has decades of combined industry experience in Submission Project Management and Submission Publishing execution.
We are prepared to submit your eCTD-compliant submissions!
Global’s dedicated eCTD publishing team has decades of combined industry experience in Submission Project Management and Submission Publishing execution.
Our team has in-depth technical knowledge of all eCTD guidance and requirements, which combined with our attention to detail, will ensure submission compliance at every step of the process. We follow industry best practices and have a keen awareness and understanding of the entire submission landscape, so we can help you establish the best lifecycle management strategy for life of your product! We are happy to work with your preferred document style and templates or to convert your content into our industry-standard, best practice style templates.
We use Certara’s GlobalSubmit™ eCTD submissions management software. We work with these exceptional tools to efficiently publish, validate, and review your eCTD submissions to support your team’s race to meet deadlines.
Contact us for more information or to set up a quick initial assessment.
Meet the Head of Regulatory Operations
Heather Sinsel, PMP, BS
Associate Director, Regulatory Operations
Location: Whitehall, PA
Favorite Biotech or Med Device Nerd Topic: Project Management, FDA guidance documents, and technical specifications for publishing!
Biggest Thrill/Adventure Completed: RAGNAR- Mt. Ascutney, Vermont
Most Important Bucket List Item: Visit all Four Hearst Castle Tours in California