What we build for pharma teams.

Corpus assembly

Regulatory reviews, assessment reports, advisory committee records, and the holds that public companies disclose in their own filings.

Comparable asset matching

Same indication, same division, same era. Then the harder question.

Transfer judgment

Deciding which precedents genuinely bear on your molecule. Most of them do not.

Risk register

Each element the regulator has contested before, with the precedent behind it and how long it held things up.

Sourced memo

One memo, one working session. Every claim traceable to the filing behind it.

Document assembly

Briefing books, response packages and submission components pulled together from what your team has already written.

Gap chasing

Missing signatures, absent rationales, unanswered queries. Found, chased and closed before the clock starts.

Response drafting

Information requests answered against what the same division accepted last time, then routed for review.

Backlog sweeps

Thousands of documents, queries or legacy records worked as one run, ranked by exposure, with daily progress reporting.

Deadline tracking

Every commitment date held in one place, with the work that has to happen before it.

Chat with your data

Ask across every precedent, filing and division in plain language. Answers in seconds.

Which divisions have contested this endpoint before?

The live precedent library

Every interaction we read, dated, sourced and filed by indication, division and protocol element.

What each division actually asks

Every precedent we flag is logged against what the regulator said afterwards.

Nexigence MCP

Bring the precedent library into the tools your team already uses.

The person who designs the protocol is the person who pays for amending it.

Draft protocol in, sourced memo out, plus a working session. Nothing to install, nothing to run.

Nexigence — Split-Feature Section (Pharma)

See the questions coming while the protocol can still change.

AutoRead

Every comparable interaction in the indication read and dated, scored against the element it bears on.

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Flagging

Each contested element raised as one line, with the precedent attached.

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Proactive Intelligence

Ask your data anything, from which division contested an element to how long it delayed them. Answers cite the filing.

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Summary

Draft protocol, pivotal design, submitted for read. Seven elements match precedents this division has contested before. Read more

Timeline

Has the division accepted this endpoint construction? At risk

The same construction was contested in twelve prior reviews, most of them in this division. Sponsors who held it saw a delay of several months. Two changed the construction and cleared without an information request.

Kept: sevenSet aside: the rest

Sourcing

Every line in the memo carries the filing behind it, so your team can check the reasoning rather than take our word for it.

Alert

Primary endpoint·construction contested

Twelve precedents, most in this division. Observed delay when held runs to several months. Raised while the protocol can still change.

Routed to reviewAt risk

Precedent attachedOpen

Proactive Intelligence

Which divisions have contested this endpoint before?

Four divisions, twelve interactions. This one accounts for most of them, all resolved by revising the construction rather than the analysis.

Precedent set — attachedView

Sent to review

Agents that own the gaps where documents stall and deadlines slip.

Intake & Assembly

From first draft to submission, agents pull the documents, chase what is missing, and flag the exposure.

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Response Recovery

Spot an unanswered request the day it lands and run the outreach that closes it.

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Deadline Assurance

Flag commitment risk while there is still time to act, then act to hit it.

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Draft protocol

Pivotal design

Open risks (4)

Awaiting sponsor decision4 pending

Primary endpoint constructionPending

Baseline thresholdPending

Paediatric planPending

Titration scheduleResolved

Activity

Working session·4 min ago

Walked the CMO through the four open risks. Agreed to revise the endpoint construction and hold the baseline threshold, with the precedent set attached for the pre-submission package. Memo updated the same day.

1:47 / 4:321.5×

Session: the endpoint first. Twelve precedents, most in your division.

Deadline Assurance

Pre-submission meeting·in three weeks

Paediatric plan still unresolved. Eleven precedents, and it has held sponsors up for months when contested. Flagged while the protocol can still change.

Suggested actionAct now

Revise before submissionSend

Know what the regulator will ask, before you finalise.

What we build for pharma teams.

Corpus assembly

Comparable asset matching

Transfer judgment

Risk register

Sourced memo

Document assembly

Gap chasing

Response drafting

Backlog sweeps

Deadline tracking

Chat with your data

The live precedent library

What each division actually asks

Nexigence MCP

"We had the design conversation internally three times. Nobody could tell me what the division had actually asked other sponsors in the same indication."

See what a division has already demanded, before you finalise the protocol.

Weeks

Two

The person who designs the protocol is the person who pays for amending it.

See the questions coming while the protocol can still change.

Agents that own the gaps where documents stall and deadlines slip.

A search tells you what the regulator published. It does not tell you which of it transfers.

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Software you keep, from a team that leaves when it works.