Dossier Submission
Understanding MHRA’s eCTD Guidance for International Recognition Procedure (IRP)

Differences in Dossier Submission Requirements: USFDA, Health Canada, EMA, and More

Pharmaceutical companies planning to market their products internationally must navigate a complex web of regulatory submission requirements. While many regions follow the ICH Common Technical Document (CTD) or its electronic version (eCTD), each regulatory authority has its own specifications, processes, and expectations.  Understanding these differences is essential for regulatory affairs professionals to avoid delays, technical […]

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