DIA Europe 2024

Even if the product is the same, the applications for marketing authorisation in Europe and the United States can look very different. This presentation will explore the major differences between EMA marketing applications (MAAs) and U.S. FDA marketing applications (NDAs/BLAs), strategies for publishing in tandem, and even means to “clone” sections for efficiency. Tips for proactive planning, eCTD publishing, hyperlink creation, and more will be shared throughout.

• Regulatory Consulting
• 505(b)2
• Expedited regulatory pathways
• Gap analysis
• Due diligence assessments

• Protocol Development, including clinical trial design, sample size calculations, SAP summaries
• SAP, TFLs, dataset and data transfer
• Study Monitoring, including DSMB, Interim Analyses
• Data Analysis, including CDISC SDTM, ADaM, and SEND dataset programming
• Pooling strategy for ISS/ISE, CDISC define.xml and other e-submission components

• Study-specific documents, such as IBs, Protocols, CSRs
• Briefing packages
• CTD Module 1-5 components, including ISS/ISE writing
• PSP/PIP
• Aggregate report writing, DSURs, PBRERs

• Submission-level eCTD publishing
• US Agent support

• AI-powered anonymisation for Policy 0070, PRCI, & EU CTR
• Strategic consulting services
• Support for CBI/CCI identification
• Protocol registration & results posting support

• Co-Author – our GenAI tool for accelerated authoring
• eCTD Authoring Template Suite – simplifying document creation

Additional Resources:

• GlobalSubmit™ eCTD Platform Factsheet
• Regulatory Operations Factsheet
• eCTD Authoring Templates Factsheet
• GlobalSubmit™ eCTD Software Webpage
• Regulatory Operations Webpage
• 10 Things to Know About eCTD 4.0
• Watch our 300 submissions milestone video
• Top Lessons Learned from 300 Regulatory Submissions

• Regulatory Submission Leadership Webpage