Nagent AI
Industry Solution

Agentic AI for
Pharma & Life Sciences

Autonomous agents that accelerate drug development research, automate regulatory submissions, scale medical affairs operations, and manage pharmacovigilance โ€” compressing timelines without compromising compliance.

Why Nagent
๐Ÿ“š

Literature at Machine Speed

Agents synthesise thousands of research papers to surface evidence in hours, not weeks.

๐Ÿ“‹

Regulatory Docs Automated

CTD and dossier sections generated from source data, ready for medical writer review.

๐Ÿ”

PV Signal Detection

Pharmacovigilance agents process case narratives and flag safety signals continuously.

Compliance-ready
ICH E6 GCPFDA 21 CFREMACDSCOISO 27001
๐Ÿ’ŠPharma-native AI
๐Ÿ“‹ICH / FDA / EMA aligned
๐Ÿ”’21 CFR Part 11
โœ…GCP-aware design
๐Ÿ“šMedical literature AI
The Shift

From AI Assistants to Autonomous Systems

Copilots assist. Agents execute. The difference is who does the work after the AI responds.

Before โ€” AI Copilots

โŒSurfaces insights, humans still execute
โŒOne-shot responses to prompts
โŒNo memory across interactions
โŒManual approval at every checkpoint
โŒStatic โ€” no improvement over time

After โ€” Autonomous Agents

โœ…Agents execute workflows end to end
โœ…Multi-step reasoning and tool use
โœ…Persistent memory via Agent Smriti
โœ…Human-in-the-loop only where required
โœ…KARMIC loop โ€” agents improve every run
Segments

Agentic AI Across Pharma & Life Sciences

๐Ÿ”ฌ Research & Drug Development

Discovery, preclinical, and early clinical phases requiring evidence synthesis and data management.

Key challenges

Literature review volume overwhelming research teams
Target identification from disparate data sources
Clinical protocol development and amendment management

Agent use cases

Systematic literature review agent
Target identification AI
Protocol development assistant
Study design reviewer
Competitor pipeline tracker
Patent landscape agent
By Department

Solutions Across
Departments

Every department has agents. Every agent has a defined input, execution, and outcome.

01๐Ÿ”ฌ Research & Evidence

3 agent solutions

02๐Ÿ“‹ Regulatory Affairs

3 agent solutions

03๐Ÿ‘จโ€โš•๏ธ Medical Affairs

3 agent solutions

04๐Ÿ” Pharmacovigilance

3 agent solutions

05๐Ÿ’Š Commercial & Marketing

3 agent solutions

06๐Ÿญ Quality & Manufacturing

3 agent solutions

๐Ÿ”ฌ

Research & Evidence

3 agent solutions

01 / 06

Systematic Literature Review Agent

Input

PICO criteria, database search strings, inclusion criteria

Agent Output

Screened citation list + evidence table + synthesis narrative

Target Identification Agent

Input

Disease mechanism data, omics datasets, patent landscape

Agent Output

Ranked target list with mechanistic rationale

Competitor Intelligence Agent

Input

Pipeline databases, clinical trial registries, publication feeds

Agent Output

Weekly therapeutic area competitive intelligence brief

๐Ÿ“‹

Regulatory Affairs

3 agent solutions

02 / 06

CTD Module Drafter

Input

Clinical study reports, preclinical data, quality documentation

Agent Output

Drafted CTD section with appropriate format and cross-references

Health Authority Query Responder

Input

HA query, existing dossier, supporting data

Agent Output

Structured response with evidence citations and action items

Labelling Update Agent

Input

New safety data, current SmPC/PI, regional requirements

Agent Output

Tracked-changes labelling update across all target markets

๐Ÿ‘จโ€โš•๏ธ

Medical Affairs

3 agent solutions

03 / 06

Medical Information Agent

Input

HCP unsolicited query, approved label, scientific data

Agent Output

On-label response with references and disclosures, for MSL review

KOL Mapping Agent

Input

Publication data, conference speaker lists, clinical trial investigators

Agent Output

Ranked KOL list by influence, specialty, and geographic reach

Publication Planning Agent

Input

Study results, congress calendar, author availability

Agent Output

Publication plan with timelines, target journals, and author assignments

๐Ÿ”

Pharmacovigilance

3 agent solutions

04 / 06

ICSR Processing Agent

Input

Adverse event case narrative (spontaneous, literature, trial)

Agent Output

Structured ICSR with MedDRA coding and reportability assessment

Safety Signal Detector

Input

Case database, disproportionality thresholds, product exposure

Agent Output

Ranked signal list with statistical evidence for PRAC review

PSUR Compiler

Input

Reporting period data, previous PSUR, benefit-risk framework

Agent Output

Drafted PSUR sections with integrated benefit-risk evaluation

๐Ÿ’Š

Commercial & Marketing

3 agent solutions

05 / 06

HCP Engagement Agent

Input

Rep territory, HCP profiles, product information, call objective

Agent Output

Personalised call plan with scientific talking points

Market Access Evidence Agent

Input

Clinical dossier, payer requirements, health economics data

Agent Output

Value dossier sections and reimbursement submission narratives

Brand Content Compliance Agent

Input

Promotional material, approved claims, code of practice

Agent Output

Compliance review with ABPI/PhRMA code reference + change requests

๐Ÿญ

Quality & Manufacturing

3 agent solutions

06 / 06

Batch Record Reviewer

Input

Executed batch record, master batch record, deviation log

Agent Output

Batch review summary with exception flags for QA sign-off

Deviation Investigation Agent

Input

Deviation event, process data, SOPs

Agent Output

Root cause analysis draft + CAPA recommendations

GMP Documentation Agent

Input

Process change, validation data, regulatory requirement

Agent Output

Updated SOPs and change control package

Live Agents

Agents You Can Try Right Now

Real agents. Real inputs. Real outputs.

๐Ÿ“š

Literature Review Agent

Screens thousands of publications against PICO criteria, extracts key data, and synthesises findings into a structured evidence table โ€” in hours rather than weeks.

Takes as input

PICO criteria
Search strings
Inclusion/exclusion criteria

Produces

Screened citation list
Evidence table
Synthesis narrative
Request Demo โ†’
๐Ÿ“‹

Regulatory Submission Agent

Drafts CTD module sections from source clinical and preclinical data โ€” formatted to ICH standards and ready for medical writer review.

Takes as input

Clinical study reports
Preclinical data packages
Target market requirements

Produces

Drafted CTD sections
Cross-reference map
Completeness check
Request Demo โ†’
๐Ÿ”

Pharmacovigilance Agent

Processes incoming adverse event case narratives, assigns MedDRA codes, assesses reportability, and generates ICSR drafts for safety assessor review.

Takes as input

AE case narrative
Product data
MedDRA dictionary

Produces

Structured ICSR
Reportability assessment
MedDRA coding
Request Demo โ†’
๐Ÿ‘จโ€โš•๏ธ

Medical Information Agent

Responds to unsolicited HCP queries with on-label information from the approved dossier โ€” with automatic out-of-scope flagging for MSL review.

Takes as input

HCP query text
Approved label and SmPC
Scientific reference library

Produces

On-label response with references
Out-of-scope flag if applicable
Disclosure statement
Request Demo โ†’
๐Ÿ”ฌ

Competitor Pipeline Tracker

Monitors clinical trial registries, regulatory databases, and publication feeds to deliver weekly competitive intelligence on your therapeutic area.

Takes as input

Therapeutic area focus
Competitor list
Monitoring frequency

Produces

Weekly pipeline update
Trial status changes
New approval alerts
Request Demo โ†’
๐Ÿ“Š

PSUR Compilation Agent

Compiles Periodic Safety Update Reports from case data, literature, and benefit-risk assessments โ€” generating draft sections for qualified person review.

Takes as input

Reporting period case data
Literature monitoring results
Previous PSUR

Produces

Drafted PSUR sections
Data tables
Benefit-risk narrative draft
Request Demo โ†’
Resources

Research & Insights

No industry-specific posts found yet.

Browse all blog posts โ†’
Integrations

Works with Your Existing Stack

Nagent connects to the systems your bank already runs โ€” no rip-and-replace.

Research & Evidence

PubMed API
Embase
ClinicalTrials.gov
WHO ICTRP
Citavi

Regulatory Systems

Veeva Vault RIM
PAREXEL Liquent
MasterControl
eCTD builders

Safety & PV

Oracle Argus
Veeva Safety
ArisGlobal
EudraVigilance
FAERS

Medical Affairs

Veeva CRM
IQVIA
Salesforce Health Cloud
medical comms platforms

+ 800 more via Composio and REST API ยท Browse all integrations โ†’

Implementation

From Pilot to Production in 8 Weeks

A structured delivery process built around your compliance requirements and existing infrastructure.

01

Function & Compliance Audit

Week 1โ€“2

Map regulatory, PV, and medical affairs workflows. Identify document production bottlenecks and compliance requirements per target market.

02

Data & System Integration

Week 3โ€“5

Connect to your regulatory vault, safety database, and literature sources. Configure ICH compliance rules and brand safety guardrails.

03

Qualified Person Review Phase

Week 6โ€“8

All agent outputs reviewed by qualified regulatory, safety, or medical professionals before submission or external communication.

04

Scale & Optimise

Month 3+

Expand across therapeutic areas and markets. KARMIC loop improves MedDRA coding accuracy and regulatory response quality each cycle.

?AARI Score

Free Assessment

5 minutes

๐Ÿ“Š
AARI โ€” Agentic AI Readiness Index

Is your pharma organisation ready for Agentic AI?

Take a 5-minute assessment to benchmark your AI maturity across strategy, data, talent, and infrastructure. You'll receive a personalised readiness score and a prioritised action plan โ€” free.

Strategy & leadership alignment
Data & integration readiness
Talent & change capability
Governance & compliance posture
Measurable Outcomes

Business Impact

0%

Faster literature synthesis

Systematic review vs manual process

0%

Reduction in dossier prep time

CTD module first draft production

48hr

ICSR processing turnaround

vs 10-day manual average

3ร—

Medical information response throughput

Same team, more HCP queries handled

โ€œOur regulatory team used to spend 6 weeks on each CTD module update. The submission agent gets us a reviewable first draft in 3 days. Our medical writers now focus on scientific quality rather than document formatting.โ€

PN

Dr. Priya Nambiar

VP Regulatory Affairs

Global Specialty Pharma ยท Pharma ยท 12 markets ยท Phase III pipeline

Playbook

The Pharma AI Playbook

Regulatory submission automation: where AI helps and where humans must lead
Literature synthesis at scale: from search strategy to evidence table
Pharmacovigilance transformation: processing volume without compromising safety
Medical affairs AI: HCP engagement, publication strategy, and KOL intelligence
Building your pharma AI roadmap: regulatory, PV, and commercial priorities
๐Ÿ“˜

Get the Playbook โ€” Free

PDF download ยท No spam

โฌก HelixBriefExecutorOutputReviewAgent Studio
Build it yourself

Design your own agents โ€” no code required

Use Agent Studio to describe your workflow in plain English. Helix, your AI system designer, will define the agent architecture, select models, configure prompts, and wire tools โ€” ready to run immediately.

Design multi-agent systems from a plain-English brief
Simulate and evaluate before going live
Connect to your existing tools and data
Self-improving via KARMIC โ€” no retraining needed
PlanBuildTestRunLearnAgentic AI Lab
Partner with us

We design, build, and deploy the agents for you

The Agentic AI Lab is Nagent's hands-on delivery service. Our team works with yours to identify the highest-impact workflows, build production-ready agent systems, and deploy them inside your environment โ€” with full knowledge transfer.

Workshop to identify high-ROI banking workflows
Custom agents built and tested for your processes
Deployed within your cloud or on-premise environment
Ongoing optimisation and performance monitoring
FAQ

Common Questions

Ready to deploy Agentic AI in Pharma & Life Sciences?

Talk to our solutions team. We'll map the right agents to your workflows and operating model.