Global Regulatory Submissions Made Simple

Global expansion sounds straightforward until you hit the real bottleneck: every country wants the same story told in a different structure, format, and language. In this Friday In-Focus session, Pure Global shares a practical playbook for making global regulatory submissions faster and simpler by leveraging existing market approvals (where allowed) and using AI to reduce repetitive drafting work while keeping human review and accountability. You will learn: • How to think about global market entry as a system, not a list of one-off submissions • Where CE Marking, FDA, and other approvals can be leveraged to accelerate entry in certain regions • Common country pathway patterns across the U.S., EU/UK, LATAM, and Asia • How an AI builder can pre-fill structured submission forms and templates, then route for human verification • What good looks like for completeness, consistency, and document control across markets • When MDSAP helps (and where it does not), plus how to use audit strategy to reduce friction Speakers (Pure Global): • Dr. Oliver Eikenberg — Global QA/RA Manager • Giulia Guerreschi — Regulatory Affairs Specialist • Michael Van Der Woude — Business Development Representative Replay and chapters below. 00:00 – Opening and speaker introductions (Pure Global team) 04:44 – Session goal: practical discussion and audience questions 05:23 – Global market landscape: where the volume and growth are 07:39 – Leveraging existing approvals: using CE marking and known regulatory systems 09:26 – Country pathway patterns across regions (Asia, LATAM, etc.) 11:06 – The real problem: how submissions get created and why it takes so long 13:03 – What AI can do today to support regulatory submissions 16:41 – AI builder example: accelerating localized submissions (Brazil use case) 29:09 – Filling structured forms with AI, then human checking and corrections 29:49 – Admin templates and structured outputs: keeping formatting consistent 32:43 – Q&A starts: completeness, consistency, and practical usage 44:18 – MDSAP discussion: where it helps versus ISO 13485 alone 57:49 – Final thanks and closing