Regulatory Software (eCTD)

Regulatory submissions and lifecycle management depend on reliable publishing and information-management software; a technical rejection at the gateway costs days at exactly the wrong moment. PharmExpert helps you select, implement and validate eCTD publishing tools and Regulatory Information Management (RIM) systems that make submissions accurate, compliant and efficient.

We define your requirements against how you actually submit — markets, volumes and lifecycle complexity — then evaluate eCTD and RIM solutions objectively. Bringing publishing in-house or implementing RIM is a significant step, and the right tool depends on your footprint, not on a vendor's pitch.

Configuration covers templates, workflows and lifecycle operations, with integration into your dossier and submission processes and a controlled approach to migrating legacy submissions and data. The system is validated to GAMP 5 and Part 11 / Annex 11 expectations.

We then train your team so they can publish confidently and validate sequences before they reach the gateway. Where you prefer publishing as a service, our Regulatory Affairs pillar provides it; here the goal is to give you a validated, well-governed capability of your own.