Life sciences regulatory and safety
Draft with every value cited for your next IND
Corvic reads your CoAs, batch records and stability reports, then fills specification and batch analysis tables. Each value links to the page it came from. A Top 10 pharma company saved 80% of its extraction and validation time.
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Or try the source extractionModule 3 build
NWX-214 tablets, 50 mg
3.2.P.5.4 Batch analyses
Draft
Dissolution, batch 2317. Stage 2 result. Sent to R. Patel, Regulatory CMC, to confirm the footnote.
Where the hours go
Your scientists spend submission weeks retyping tables
Module 3 values start life in CoAs, batch records, LIMS exports and development reports. Someone copies each one into a template, and someone else checks it.
01
Every value gets typed twice
A writer copies results from the CoA into 3.2.P.5.4. A verifier opens the same CoA and checks each cell. A 40-batch table means hundreds of lookups before anyone reads it for meaning.
02
One parameter lives in many places
A tightened impurity limit touches 3.2.P.5.1, Module 2.3 and each country dossier. Miss one and it comes back as a health authority question on the variation.
03
Case intake eats the safety budget
Case processing takes 40% to 80% of pharmacovigilance budgets (Deloitte survey, via Indegene). Literature screening runs every week on top of that, as EMA GVP Module VI expects.
What Corvic does
Six document jobs Corvic drafts for your reviewers
Each job ends in a table or record your team checks against the source. Corvic drafts and cites. Your qualified people decide what goes into the submission.
Batch analysis tables from CoAs
Corvic reads each certificate of analysis, matches tests to your specification, and fills one row per batch. Values it cannot read cleanly, like a handwritten correction, go to a person.
Draft 3.2.P.5.4 table with a page link on every result
Specification and stability tables
Pull acceptance criteria for 3.2.S.4.1 and 3.2.P.5.1. Pull results by condition and time point for 3.2.P.8.3, from protocols and stability reports in any layout.
Spreadsheet in your template, ready for author review
Consistency checks across the dossier
Compare the same parameter across Module 3, the QOS and source reports. Corvic lists each mismatch, such as a pH range that differs between the batch record and the specification.
Discrepancy list by section, with both sources quoted
Variation impact search
Ask where a manufacturing site, supplier or limit appears across every dossier you hold. Corvic searches by meaning, so it finds the passage that describes the limit without naming it.
List of affected sections and pages for the change
Weekly literature screening
Corvic pulls new PubMed records for your products on a schedule. It flags articles that describe an individual patient, a suspect product and an adverse reaction.
Screening log with a cited reason for each include or exclude
Adverse event intake and evidence tables
Turn emails, call notes and forms into a pre-filled intake record. For medical affairs, build evidence tables with design, sample size and endpoints from each paper.
Records and tables where each field cites its source line
Try it
Pick a source document and check every field
Choose a document. Corvic pulls the fields your template needs and links each one to where it sits on the page. Values it is unsure of go to a reviewer, with the reason attached.
1. Pick a source document
Source
p. 1 of 2
- 1Northwind Biologics · Harbor Fill-Finish site
- 2CERTIFICATE OF ANALYSIS
- 3Product: NWX-214 tablets, 50 mg
- 4Batch: 2317 Mfg date: 2026-04-02 Size: 410,000 tablets
- 5Test | Method | Acceptance criterion | Result
- 6Description | Visual | White, round, debossed 214 | Conforms
- 7Assay | HPLC-UV, TM-0412 | 95.0 to 105.0% LC | 98.9% LC
- 8Total impurities | HPLC-UV, TM-0413 | NMT 1.0% | 0.37%
- 9Dissolution, 30 min | USP <711> | Q = 80% | 86% (S2) *
- 10Water content | KF, TM-0108 | NMT 3.0% w/w | 1.9%
- 11* Stage 1 not met. Tested to stage 2 per USP <711>.
- 12Conclusion: Batch complies with specification NWX-214-SPC-03.
- 13Released by QA: Dana Whitfield 2026-04-19
Select a field to see the line it came from.
2. Check the record
Row for 3.2.P.5.4 Batch analyses
Reading Certificate of analysis
Review queue (0)
Nothing sent yet. Flagged values wait here until a reviewer decides.
How it works
From source files to a reviewed table in three steps
Corvic works on files where they already sit. Your RIM, DMS and publishing tools stay as they are.
- 1
Connect the source files
Point Corvic at CoAs and reports in SharePoint, S3 or Azure Blob, and at LIMS exports in Snowflake or Databricks. Nothing has to move.
- 2
Map fields to your template
Define the columns once, such as test, method, acceptance criterion and result per batch. A playbook runs the same mapping on every new batch.
- 3
Review flags, then export
Uncertain or conflicting values go to a named reviewer with the reason. Approved tables export as spreadsheets your authors place in the template.
PubMed
Microsoft 365
Google Drive
AWS S3
Azure Blob Storage
Snowflake
DatabricksProof
A Top 10 pharma moved CMC dossiers off manual cross-referencing
Subject matter experts spent weeks per submission matching tables by hand. Corvic now parses the dense tables, cross-references parameters like pH and temperature across documents, and fills submission spreadsheets.
80%
Time saved on data extraction and validation
5x
Throughput on regulatory dossier processing
100%
Compliance rate against the customer's accuracy requirements
Top 10
Global pharmaceutical company, CMC submissions
Read how the pharma team did it
Why retrieval chatbots lost the context in 500-page dossiers, and what replaced them.
Research Paper Analysis playbook
Extract tables and figures, summarize methods and build a literature matrix with a citation per claim.
Molecule-Target Pathfinder agent
Links assay results, literature, patents and trial data in one graph for discovery teams.
Security
Deployment terms your quality team can review
Tell us your compliance requirements before the pilot. We scope the deployment, the data in scope and the review steps with your quality and IT teams.
Private VPC deployment
Run Corvic inside your own cloud network. Tenants are isolated, and your documents stay in your environment.
SOC 2 Type II
Corvic holds a SOC 2 Type II report. It is GDPR and CCPA compliant, and customer data is removed on request.
Encryption and your keys
AES-256 at rest and TLS 1.2 or higher in transit, with customer-dedicated key management.
Zero data retention options
Choose models with zero data retention where the provider supports it. Swap models in configuration without rebuilding the workflow.
A source link on every value
Each extracted value points to its document, page and table cell. Reviewers check the source instead of searching for it.
Permissions per person and source
Corvic respects existing access. A PV case processor sees safety sources only, and a CMC writer sees CMC sources only.
Common concerns
Concerns from regulatory and safety teams
Every value Corvic returns is read from a source page and links back to it. Your verifier clicks the link and sees the cell. When a value is unclear, such as a handwritten correction or a stage 2 result, it goes to a reviewer instead of the table.
Corvic does not claim validated GxP status. Teams use it to draft tables and records that authors and verifiers check under your existing SOPs. FDA's January 2025 draft guidance on AI puts drafting a regulatory submission out of its scope. That holds when the use does not affect patient safety, drug quality or study results. Tell us your requirements and we will scope the use with your quality team.
Deploy Corvic in a private VPC with tenant isolation and your own keys. Pick models with zero data retention where the provider offers it. For patient-level safety data, tell us your requirements first and we agree what is in scope.
Corvic sits beside them. It reads files where they are stored and returns tables and spreadsheets in your templates. Your authors and publishers keep their current tools and process.
That is the problem the Top 10 pharma team brought to Corvic. Corvic keeps each number tied to its row, column and table, then cross-references parameters across documents. The team saved 80% of its extraction and validation time.
Send one product's documents for one section, such as the CoAs behind 3.2.P.5.4. We onboard you with those files, and your first answer arrives within 24 hours. The pilot stays that narrow until your reviewers trust the output.
Pick OpenAI, Anthropic, Google, xAI, an open source model or your own endpoint. Run the same extraction across models and compare quality, latency and cost before you choose. Changing models is a configuration change, and your team decides when it happens.
Start with one section on your own documents
Pick one product and one Module 3 section, such as batch analyses. We onboard you with those files, and your first answer arrives within 24 hours.
Accounts are free. No credit card needed.
See the pharma case study