AI Annotations Built
For Pharma Documentation
Highlight protocol gaps, SAP inconsistencies, and labelling risks
where reviewers already work - directly inside the PDF viewer.
Protocols / SAP & CSR / SOP / Labeling / CAPA
Interactive demos across pharma workflows
Switch between protocol QA, SOP review, labelling alignment, and PV signal triage to see annotation-ready output in action.
Sample clinical protocol
Upload your own protocol, SAP, or CSR to mirror this workflow.
Cleanroom SOP update
See how the agent flags alert/action inconsistencies and CAPA linkages in SOP drafts.
SmPC vs PI alignment
Compare market labelling language and surface contraindication or warning gaps.
PBRER signal triage
Let the agent consolidate safety signals and MedDRA coding actions for pharmacovigilance.
Clear use cases for every pharma function
Map the agent to your SOPs in hours. Each use case below ships with ready-made prompts, annotation styles, and compliance guardrails.
Clinical development / Medical writing
Challenge
Protocol, SAP, and CSR alignment checks consume days and issues are still found during review board.
How the agent helps
Cross-links evaluation criteria, visit schedules, and analysis populations, highlighting mismatches and jumping reviewers to the exact paragraph.
Example annotation
[High] SAP section 3.2 analysis cohort does not match Protocol section 5.1. Review linked paragraphs.
Clinical operations (audit response)
Challenge
Audit findings live in long email chains and assembling evidence packs is manual.
How the agent helps
Keep observation, corrective plan, and supporting documents inside one PDF comment thread so the full story is inspection ready.
Example annotation
Audit-012 thread: Observation -> Corrective action -> Evidence attachment captured in PDF.
Nonclinical / CMC
Challenge
Unit conversions, release specs, and lot metadata drift across large submission packages.
How the agent helps
Extract numeric fields, compare them to master specifications, and highlight deviations directly in stability reports and batch records.
Example annotation
Lot 24B torque spec differs from last qualified lot 23Q by +12%.
IRB / IEC submissions
Challenge
Patient-facing materials mix complex terminology with missing required statements.
How the agent helps
Classifies hard-to-read sentences, suggests plainer alternatives, and flags absent consent language so committees sign off faster.
Example annotation
[Medium] Replace jargon: "Patients will visit four times" suggested for section 2.1.
Quality assurance / GxP
Challenge
Revision projects miss critical warnings, torque values, or rationales buried in SOP text.
How the agent helps
Pre-highlights critical instructions, captures reason-for-change comments, and keeps revision history auditable in the PDF.
Example annotation
[Alert] SOP-17 section 4.3 torque value removed compared to prior revision.
Manufacturing and QC
Challenge
Batch record templates vary by site and CAPA follow-up stalls on missing entries.
How the agent helps
Detects mandatory fields left blank, tags them with "Evidence required" comments, and tracks completion status across batches.
Example annotation
Tag: Evidence required -> CAPA-552 deviation summary not documented.
Regulatory affairs (labelling / eCTD)
Challenge
Maintaining consistency between SmPC, PI, IFU, and submission modules is tedious and error prone.
How the agent helps
Diffs labelling language, highlights prohibited terms, and links annotations to source evidence for faster justification.
Example annotation
[High] Term "cure" detected in PI section 4.1. Refer to labelling policy LP-203.
Pharmacovigilance (PBRER / PSUR / RMP)
Challenge
Safety reports ship with missing sections or inconsistent MedDRA coding.
How the agent helps
Checks structure against required templates, suggests code harmonisation, and flags sections still marked incomplete.
Example annotation
Section 4.8 flagged: MedDRA preferred term for rash inconsistent with case series appendix.
Commercial review / Medical affairs
Challenge
Promo materials require rapid turnaround but claims and references are hard to verify at scale.
How the agent helps
Highlights comparative or superlative claims, prompts for evidence, and tags missing references before approval meetings.
Example annotation
To-do: Provide Phase III ORR reference for slide 12 claim before sign-off.
Legal, procurement, and security
Challenge
CRO MSAs and DPAs hide key differences in IP ownership, subcontracting, or liability language.
How the agent helps
Color-codes clauses by risk, extracts limitation language, and notifies reviewers when terms break policy thresholds.
Example annotation
Risk: Indemnity cap in Exhibit B exceeds template baseline by 50%.
Built around pharma documentation bottlenecks
The agent reads every page, cross-references master data, and posts highlights straight onto the PDF, so clinical, quality, and regulatory teams stay aligned.
Protocol / SAP / CSR integrity
Detect mismatches in endpoints, visit schedules, and analysis populations before QC flags them.
[High] SAP 3.2 analysis cohort != Protocol 5.1. Jump to paragraph
Audit readiness threads
Respond to audit findings in a single annotation thread - from observation to corrective evidence.
Audit-001 -> Investigator email + CAPA plan linked in thread
Unit & lot normalization
Surface inconsistent units, specs, and lot metadata with auto-highlighted diffs against prior versions.
Lot 24B torque spec deviates from 23Q baseline
Readability & required clauses
Flag jargon and missing consent statements; insert ready-to-use patient friendly language inside the PDF.
[Medium] Suggest: "The study requires four clinic visits."
Critical instruction safeguard
Highlight torque values, warnings, and revision rationales so SOP updates never miss compliance-critical text.
[Alert] SOP-17 section 4.3 torque value removed in latest draft
Batch record completeness
Auto-tag blank mandatory fields and add "Evidence Required" annotations to speed CAPA close-out.
Tag: Evidence Required -> CAPA-552 missing deviation summary
Labeling & eCTD cross-check
Compare SmPC / PI language, spot banned terms, and link back to supporting references via comment threads.
[High] "Cure" phrasing conflicts with JP label guidance
PSUR / RMP governance
Confirm required sections, suggest MedDRA code harmonization, and mark unaddressed safety updates.
Section 4.8 missing MedDRA PT for rash events
Promo asset scrutiny
Highlight over-claims, comparative statements, and request evidence before approval workflows move forward.
To-do -> Provide Phase III reference for ORR claim
Contract risk surfacing
Color-code clauses around IP ownership, indemnity, and subcontractors to help legal triage vendor agreements.
Risk: Indemnity cap exceeds master template
How teams ship audit-ready PDFs in hours
Purpose-built prompts, annotation templates, and export options map to the documents you already manage today.
1. Upload with context
Drop your protocol, SOP, or labeling PDF and add quick instructions like target endpoints, banned phrases, or CAPA IDs.
2. Let the agent annotate
The agent cross-checks related documents, highlights mismatches, and opens comment threads your SMEs can edit in place.
3. Export and archive
Download annotated PDFs, export audit trails, or push threads to your QMS so every action is traceable.
Pricing Plans
Choose the plan that fits your needs. Start for free and scale as you grow.
Free
For individuals and small projects getting started.
$0
/ user / month
- Up to 10 file uploads
- Multi-file analysis
- WebSearch Integration
- FileSystem Integration
- Background & Chat Ops
- Self-hosted Cloud Deployment
- Customer Support
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Pro
For professionals and teams requiring advanced features.
$5
/ user / month
- Unlimited file uploads
- Multi-file analysis
- WebSearch Integration
- FileSystem Integration
- Background & Chat Ops
- Self-hosted Cloud Deployment
- Email Support
Enterprise
For large organizations with custom needs and security requirements.
Ask
- Unlimited file uploads
- Multi-file analysis
- WebSearch Integration
- FileSystem Integration
- Background & Chat Ops
- Self-hosted Cloud Deployment
- Dedicated Support & SLA
Ready to pilot with your regulated PDFs?
Share a work email and we will spin up a secure sandbox with pharma-ready prompts, annotation templates, and onboarding for your team.