Regulatory Tools
From Regulatory Uncertainty to an Executable Strategy
These tools are free and require no email. They are designed to structure the question, so that any conversation that follows starts from evidence.
Tool 01
Find Your Regulatory Pathway
Six inputs produce an indicative pathway, the documentation typically expected and the risks most often underestimated.
Tool 02
How Submission-Ready Is Your Dossier?
Rate each area of your package. The score is indicative and intended to prioritise work, not to predict an assessment outcome.
Tool 03
CTD Explorer
Select a module to review its purpose, typical documents and the deficiencies assessors raise most often.
Module 1 — Regional Administrative Information
Region-specific administrative content, application forms and labeling.
Typical documents
- Application forms
- Cover letters
- Proposed SmPC/PIL/labels
- Certificates
Common deficiencies
- Outdated regional forms
- Labeling inconsistent with Module 3
- Missing legalised GMP or CPP documents
Regulatory requirements vary by product, jurisdiction and development stage. Information provided on this website is for general informational purposes and does not constitute legal, medical or formal regulatory advice. Regulatory decisions should be confirmed against current requirements and, where appropriate, with the relevant health authority.
Next Step
Have the Output Reviewed by a Regulatory Professional
Send us your tool output and we will tell you what we would verify first, and why.