From scattered documentation to a submission-ready dossier.
Bloom turns study reports, manufacturing records and specifications into eCTD dossiers for Anvisa. AI agents draft each section with its source cited, and a regulatory expert verifies and signs off before delivery.
- Every data point reaches the dossier with its source file, page and passage
- No dossier is delivered without a regulatory expert's approval
Every inaccuracy becomes an exigência, and every exigência delays the registration.
An exigência is Anvisa's formal request for clarification on a submission. Here are three failures that cost months, and what the platform does about each one before the dossier reaches your desk.
A value differs between two sections
The discrepancy becomes a recorded open item. When the same data point appears in two documents with different values, the platform records the discrepancy and points to both sources. The choice stays with whoever has the context to decide, and it appears in the audit kit.
A claim the source document does not support
A citation is mandatory for every claim. Every sentence produced carries a reference to the passage that supports it. A sentence without a reference is treated as a defect by the next layer, which takes away the agent's option to fill in what merely sounds plausible.
A field filled in by assumption
The agent declares what is missing. When the source does not support a field, the agent records the gap and moves on. The field reaches the expert flagged as open, with a note of what is missing, and is resolved before filing.
Four layers between the document and the dossier
No single step guarantees accuracy. What holds the result up is the sequence: each layer checks the work of the one before, and the last one is human.
Layer 1 · Extraction: Every data point is born with an address
Every value read keeps the file, page and passage it came from, and that reference travels with it into the final dossier and the audit kit.
Layer 2 · Drafting: One specialised agent per section
Each section is filled in by an agent given that section's rules: what Anvisa expects, the required format, approved examples and where the information usually sits in the CTD.
Layer 3 · Evaluation: The judge did not write it
Evaluator agents that took no part in drafting check the output against the sources and against the section's acceptance criteria.
Layer 4 · Verification: An expert reviews and signs
A regulatory expert reviews section by section, resolves what the evaluators flagged, closes the open items and signs. Responsibility for what is delivered stays with a person.
Every section of the dossier has its own rules
A generic agent gets it wrong exactly where the detail matters. At Bloom, the agent that fills a section is given what Anvisa expects from it, and the agent for the next section is given a different set. Some examples:
- API specification (M3.2.S.4.1): Mandatory parameters, limits, pharmacopoeial reference and the table format.
- Analytical method validation (M3.2.S.4.3): The parameters required by RDC 166/2017 and the summary for each validation report.
- Batch analyses (M3.2.P.5.4): Batches, scale, manufacturing site and result per parameter.
- Manufacturing data (M3.2.P.3.2 · P.3.3): Master formula, flow chart, critical steps and equipment.
- Stability (M3.2.P.8): Conditions, time points, packaging and proposed shelf life.
The rules reach the agent as instructions, examples and criteria at the time of the work. No model is fine-tuned or trained on client documents.
A change to the platform goes through the same proof your department requires
An eval is the systematic, repeatable assessment of output against an expected result. The logic is that of a quality control test: there is a reference standard, an acceptance criterion defined before the test, and the result is recorded.
What the evaluator checks in every section
- Every claim is supported by the cited passage
- The section's mandatory fields are filled in
- The section does not contradict another part of the same dossier
- Format and terminology follow what Anvisa requires
- Units, dates and identifiers are consistent
- Anything marked not applicable has a justification
No dossier is delivered without a regulatory expert's approval.
Alongside the dossier, the record of how it was built
So that any claim can be defended months later, by someone who took no part in the work.
Provenance map
Every claim in the dossier linked to the file, page and passage it came from. It answers in seconds where a questioned number came from.
Points of uncertainty
Where the source was ambiguous, where more than one reading was possible and where two documents disagreed, with the sources involved and the reading adopted.
Items requiring confirmation
Data only your company can confirm, listed as explicit open items before filing, with a note of who usually holds the information.
Coverage and verification report
Sections completed, sections marked not applicable with their justification, and what each verification layer flagged along the way.
Frequently asked questions
Does Bloom replace my Regulatory Affairs team?
No. The agents do the heavy lifting of reading, organising and drafting, so people spend their time on what takes judgement. The decision about what goes to the regulator belongs to a qualified person, and the open items only your company can resolve come back to it as explicit questions.
Who is responsible for the dossier's content?
A regulatory expert. They review section by section against the cited sources, resolve what the evaluators flagged, close the open items and sign. The delivery goes out with a name, a date and a record of everything changed relative to what the agents produced.
What happens when the documentation does not support a field?
The agent records the gap instead of filling it in by assumption. The field reaches the expert flagged as open, with a note of what is missing, and anything only your company can confirm appears in the audit kit as an explicit open item before filing.
What if two documents give different values for the same data point?
The platform records the discrepancy and points to both sources. The choice stays with whoever has the context to decide, and the discrepancy appears in the audit kit with the reading adopted.
Are my company's documents used to train models?
No. The agents' specialisation comes from instructions, examples and rules provided at the time of the work. No model is fine-tuned or trained on client documents.
Who has access to my documents?
The smallest possible number of consultants assigned to the project, with scope limited to the contracted service: each one reaches only that dossier's documents. Credentials are individual, with a unique, random, strong password plus two-factor authentication, and every access is logged: who, when, and what was viewed or changed. Our Data protection and information security document covers where the data is stored.
How do you make sure a platform update does not make results worse?
With a fixed reference set that grows with every new case. When a model, an instruction or a rule changes, the whole set is reprocessed and the outputs are compared with the approved ones. If a section that used to be correct starts to diverge, the change is held until the cause is understood.
What do I receive at the end?
The dossier in eCTD format and the audit kit: the provenance map for every claim, the points of uncertainty, the items that need your company's confirmation and the coverage and verification report.
Which CTD sections does the platform prepare?
Each section of the dossier is filled in by an agent with its own rules. Some examples: API specification (M3.2.S.4.1), analytical method validation under RDC 166/2017 (M3.2.S.4.3), batch analyses (M3.2.P.5.4), manufacturing data (M3.2.P.3.2 and P.3.3) and stability (M3.2.P.8). To find out whether your case is covered, write to our team.
Can my Quality Assurance team qualify Bloom as a supplier?
Yes. We answer your company's supplier qualification questionnaire, present the validation method and show the audit kit. Write to our team.
Is Bloom affiliated with Anvisa?
No. Bloom prepares the material your company submits to Anvisa and follows the format and terminology the agency expects. Anvisa is a trademark of the Agência Nacional de Vigilância Sanitária.
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