Declared gap or filled-in field?
When the documentation does not support a dossier field, recording the gap resolves it before filing. Filling it by assumption becomes an exigência.
Every dossier has fields the documentation does not fully support. A stability report that does not state the packaging used in the study. An API specification that refers to a certificate nobody attached. A batch cited in the analysis that does not appear in the manufacturing record.
Faced with a field like that, there are two ways out. The first is to record that something is missing, say what, and move on. The second is to fill the field with whatever seems most likely. For anyone drafting in a hurry, and for any language model, the second is always the more tempting: the dossier looks complete.
Why the assumption costs more
A field filled in by assumption does not go away. It waits. When the reviewer at Anvisa finds a value that does not match the rest of the dossier, or that no attached document supports, the result is an exigência, Anvisa's formal request for clarification. And every exigência delays the registration.
A declared gap takes the opposite path. It reaches whoever can resolve it before filing, with an exact note of what is missing. Sometimes the answer is in a document the company has and did not send. Sometimes the field needs to be revisited. Either way, the decision happens in-house, not in a reply to the regulator.
How Bloom handles a gap
On the platform the rule is simple: when the source does not support a field, the agent records the gap and moves on. It does not fill in what merely sounds plausible. Three mechanisms make sure of that:
- Mandatory citation. Every claim produced carries a reference to the passage that supports it: file, page and passage. A sentence without a reference is treated as a defect by the next layer. An agent that filled in by assumption would have nothing to cite.
- Independent evaluation. A second agent that took no part in drafting checks every section against the sources and asks, among other things, whether each claim is supported by the cited passage. Whatever fails goes back for redrafting.
- A visible open item. The field reaches the regulatory expert flagged as open, with a note of what is missing. The expert decides what can be completed from the material available and what has to go back to the company as a question.
What shows up in the delivery
Alongside the dossier, the audit kit includes a list of items requiring confirmation: data only the company can confirm, listed as explicit open items before filing, with a note of who usually holds the information. It also includes the points of uncertainty, where the source was ambiguous or two documents disagreed, with the reading adopted.
That record matters beyond filing. Months later, when someone asks why a field has that value, the answer is written down: where it came from, what was in doubt and who decided.
In short
A declared gap is resolved before filing. A gap filled in by assumption shows up later as an exigência. The difference between the two is not a matter of technology but of rules: the system has to be forbidden from inventing, and there has to be a layer that checks it obeyed.
If you would like to see how this looks in a real dossier, write to our team.