Dossier Review, Compilation, eCTD Conversion & Submission

A well-built dossier is the difference between a smooth approval and a cycle of deficiency letters. Reviewers form an impression quickly, and a navigable, well-argued dossier signals a capable applicant. PharmExpert reviews and compiles CTD dossiers, converts and publishes compliant eCTD sequences, and submits to FDA, EMA, MHRA and rest-of-world authorities — managing authoring, formatting, publishing and validation end to end.

We begin with a dossier review and gap analysis, then assemble Modules 1–5 with the correct region-specific Module 1 for each market. Granularity and hyperlinking are built to each agency's specification, because structure that is hard to navigate or maintain creates problems for reviewers now and for variations later.

Every sequence is technically validated against the relevant agency specification before it reaches the gateway — the discipline that prevents avoidable technical rejections at exactly the moment timelines matter most.

We submit through the appropriate gateway and manage the dossier across its lifecycle, and we handle baseline and legacy-to-eCTD conversion where you are moving formats. The result is right-first-time submissions across markets and a dossier that stays coherent over its whole life.