Separate known requirements from assumptions
Build an evidence register that shows the source, owner and confidence behind each requirement. Flag items that need legal, technical or regulatory confirmation.
Connect approvals to the commercial plan
A certification delay can change inventory timing, channel agreements and cash needs. The regulatory pathway is therefore a commercial workstream, not a final technical check.
Design claims around evidence
Marketing language should follow what can be substantiated in Australia. This creates a credible promise and reduces rework close to launch.
The decision standard
The objective is not to remove all uncertainty. It is to make the customer, commercial logic, evidence, dependencies and next test visible enough for a responsible decision.
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