Product Registration & Dossier Management

Product Registration & Dossier Management

A registration dossier is not a compliance document—it's your sales pitch to a regulator. If it's boring, unstructured, or misaligned with what the regulator actually cares about, it gets objections, delays, or rejection. We write dossiers that earn approvals.

Our team has prepared over 400 successful product applications across PPB, SAHPRA, NAFDAC, and EAC frameworks. We handle the technical writing (CTD or local format), gather missing data, coordinate Quality Overall Summaries with your manufacturer, and prepare responses to regulatory queries. When PPB returns technical objections—and they often do—we interpret what they're really asking, coordinate with your chemist or manufacturer, and resubmit in a way that resolves the issue cleanly.

We also manage the regulatory workflow. You submit once, and we track the dossier through each stage—receipt, completeness check, substantive review, query cycles, and approval. Most clients don't know what's happening between submission and approval. We keep you updated, anticipate bottlenecks, and communicate directly with the regulator when needed.