The regulator sets the deadline. Your team absorbs the change
Visium builds the authoring layer around regulatory submissions. CTD modules drafted from your source data and your templates, health authority questions answered from what you have already filed, gaps against current guidance named before an assessor names them. Every statement traces back to the data behind it, so review time goes to the science.
The submission timeline problem
Ask a regulatory lead where a submission timeline actually goes and the answer is rarely the science. It goes to authoring, reconciliation and review, carried out by the people whose judgement is the scarcest thing in the function.
The same content, authored again for every market
A dossier, then a variation, then a second region with different expectations. Most of what goes into each version was written and approved somewhere already. Where content is held as finished documents and registration data disagrees between systems, every version starts from an empty section.
Your scarcest people spend their week assembling
Regulatory writers, medical reviewers and data owners hold the judgement in this function. Much of their time goes to locating source data, reconciling numbers across modules and formatting to a standard. Submission volume rises with the portfolio. Headcount does not follow.
Questions arrive on a clock you did not set
A health authority query lands with a fixed response window. The answer usually exists somewhere across prior submissions, study reports and internal correspondence. Finding it is the work, and the window closes on schedule regardless.
Precedent leaves when people do
What the agency accepted last time, which justification held, what wording survived review. That knowledge sits with individuals and inside dossiers nobody searches, so each team rediscovers it at its own cost.
And the reader is trained to find what you missed
Every document here is assessed by someone whose job is to locate the distance between what you claim and what you evidenced. A statement that cannot be traced to the study, the batch or the prior filing behind it becomes a question you answer later, under a clock. Traceability to source is where this build starts.
Ten regulatory workflows. We start most engagements with three of them.
These three carry the clearest cost of delay and the shortest path to a measurable result.
Submission dossier authoring
Draft CTD modules from your source data, your templates and what you have already filed. The first version arrives with the data pulled in and the structure correct, so authors begin with a draft under review.
Drafted sections with every statement linked to the source behind it, formatted to your templates and the eCTD structure.
Health authority query response
A question arrives with a fixed window. The system assembles what you have already filed on the point, what you argued in comparable submissions and the data underneath both, then drafts the response.
A drafted answer with prior filings and supporting data attached, and a named list of what your record does not cover.
Regulatory gap and compliance checking
Check the dossier against current guidance, against your own prior submissions and against itself. Inconsistencies between modules, statements without supporting data and sections that no longer meet current expectations are named before you submit.
A gap list per document, each item pointing at the section, the requirement and the evidence behind the flag.
Structured content and data reuse
Hold content as reusable components instead of finished documents, so approved text and data carry across markets, variations and document types.
Variation management
Identify which registrations a change touches, classify the variation type per region, and assemble the supporting documentation from what has already been filed.
IND/IMPD assembly
Build the first-in-human package from nonclinical, CMC and clinical source material, with gaps against regional expectations named early enough to close them.
Label and SmPC generation
Draft and maintain labelling from the approved core text, with differences between markets visible and the reason behind each one on record.
Regulatory intelligence monitoring
Track changes in guidance and authority positions, and map each change onto the submissions, registrations and documents it reaches.
RIM data governance
Reconcile registration data across systems and regions, and show where the same product, substance or registration is described inconsistently.
Precedent search
Find what you submitted before, what was accepted, what was questioned and how you answered, across your full submission history.
What we bring to a discovery programme
Discovery teams do not need another general model. They need scientific judgement encoded in something reviewable, running on their own data, inside their own environment.
Configured to your templates, your data and your review process
Upload your document standards and connect your source systems. The first configuration runs against your requirements from day one, so authors recognise the output as their own house style.
Traceability on every statement
Each drafted sentence links back to the data, the study or the prior filing it came from. In our pathology work a reviewer sees the extracted value highlighted inside the original report and confirms it in seconds. The same principle governs a CTD section.
The investment compounds across document types
Once the core workflow is configured, adding a document type reuses the source connectors, the review logic and the audit architecture already in place.
Deployed inside your environment
Each flag, score and drafted line links back to the document, the version and the page. In our pathology work a reviewer sees the extracted value highlighted in the original report and confirms it in seconds. Audit trails on agent activity, role-based access and GxP-compliant model versioning come as part of the build.
Quality decisions with the data behind them
Discovery buyers ask for validated performance, published methods and named collaborations. Here is what we have on record.
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