New

Designing Better Systems for Pharma
& Biotech

We help pharma and biotech teams streamline operations and design smarter internal workflows using AI where it adds real value, not clutter.

Our Services

Streamlining Pharma Operations

Most pharma teams are slowed down by outdated workflows. We help you streamline processes, reduce compliance risk, and regain operational clarity.

All Tasks

Waiting for approval

  • SOP Document Review

    Due in 3 days

  • Clinical Site Status Update

    2 days ago

  • Regulatory Submission Tracker

    Awaiting Response

  • CAPA Task Follow-up

    70% prepared

  • Payment reminder

    sent to selected clients

All Tasks

Waiting for approval

  • SOP Document Review

    Due in 3 days

  • Clinical Site Status Update

    2 days ago

  • Regulatory Submission Tracker

    Awaiting Response

  • CAPA Task Follow-up

    70% prepared

  • Payment reminder

    sent to selected clients

All Tasks

Waiting for approval

  • SOP Document Review

    Due in 3 days

  • Clinical Site Status Update

    2 days ago

  • Regulatory Submission Tracker

    Awaiting Response

  • CAPA Task Follow-up

    70% prepared

  • Payment reminder

    sent to selected clients

Business Operations Automation

Automate Internal Pharma Operations & Task Flows

Pharma teams waste hours every week on manual processes like data entry, status tracking, and approval chains. We help you identify these slow, error-prone workflows and automate them — freeing up your team to focus on high-value tasks like compliance oversight, clinical operations, and strategy.

Internal Task Bots

100+ Automations

Pharmacovigilance Automation

Automate Adverse Event Reporting & ICSR Case Processing

Pharmacovigilance teams spend countless hours manually reviewing case reports, structuring data, and pushing submissions. We automate these workflows end-to-end — from intake to E2B-ready reports — freeing up your team for strategic safety oversight.

ICSR Bots

Safety Data Extraction

ICSR Automation Engine

Automate adverse event intake and reporting — free your team from manual case processing.

|

Upload an ICSR Document

Generate Report

Validate Case

ICSR Automation Engine

Automate adverse event intake and reporting — free your team from manual case processing.

|

Upload an ICSR Document

Generate Report

Validate Case

ICSR Automation Engine

Automate adverse event intake and reporting — free your team from manual case processing.

|

Upload an ICSR Document

Generate Report

Document Workflow Status

Submissions

Approvals

Audit Tasks

Draft

Schedule

Sent

Document Workflow Status

Submissions

Approvals

Audit Tasks

Draft

Schedule

Sent

Document Workflow Status

Submissions

Approvals

Audit Tasks

Draft

Schedule

Sent

Regulatory Operations Automation

Streamline Document Workflows & Submission Readiness

Manual tracking of regulatory document versions, approvals, and submission statuses slows teams down and increases compliance risks. We build automations that manage document workflows, submission trackers, and audit prep tasks — so nothing slips through.

Regulatory Submission Trackers

Document Validation

Custom Automation Projects

Tailored Automations for Your Unique Pharma Workflows

We design these custom automations to fit the needs of every team across the industry — from CROs streamlining recruitment and compliance, to biotech startups scaling lean operations, to global pharma organizations managing regulatory submissions and pharmacovigilance at scale.

Strategy

Custom AI

Operational Consulting

Recruitment Dashboard – CRO Team

Automated workflows designed for faster candidate sourcing & compliance.

Ongoing Automation Build:

Candidate Matching & Follow-Up

75% Complete

Project Milestones

Mo

Tu

We

Th

Fr

Sa

Su

Candidate Data Upload

Completed

Automated Shortlisting

In Progress

Recruitment Dashboard – CRO Team

Automated workflows designed for faster candidate sourcing & compliance.

Ongoing Automation Build:

Candidate Matching & Follow-Up

75% Complete

Project Milestones

Mo

Tu

We

Th

Fr

Sa

Su

Candidate Data Upload

Completed

Automated Shortlisting

In Progress

Recruitment Dashboard – CRO Team

Automated workflows designed for faster candidate sourcing & compliance.

Ongoing Automation Build:

Candidate Matching & Follow-Up

75% Complete

Project Milestones

Mo

Tu

We

Th

Fr

Sa

Su

Candidate Data Upload

Completed

Automated Shortlisting

In Progress

Our Process

Our Simple, Smart, and Scalable Process

We design, develop, and implement automation workflows that streamline Pharma operations — reducing manual workload, improving compliance, and scaling with your business.

Step 1

Smart Workflow Analysis

We assess your current processes (PV, Regulatory, Clinical Ops) to identify bottlenecks and map where automation can save time, reduce errors, and streamline compliance workflows.

Analyzing current workflow..

System check

Process check

Speed check

Manual work

Repetative task

Analyzing current workflow..

System check

Process check

Speed check

Manual work

Repetative task

Step 2

Custom Automation Development

Our team builds intelligent automation systems tailored to your specific pharma workflows — ensuring regulatory alignment and operational efficiency.

  • class AutomationTrigger:
    def __init__(self, threshold):
    self.threshold = threshold
    self.status = "inactive"

    def check_trigger(self, value):
    if value > self.threshold:
    self.status = "active"
    return "Automation triggered!"
    else:
    return "No action taken."
    def get_status(self):
    return f"Status: {self.status}"

  • class AutomationTrigger:
    def __init__(self, threshold):
    self.threshold = threshold
    self.status = "inactive"

    def check_trigger(self, value):
    if value > self.threshold:
    self.status = "active"
    return "Automation triggered!"
    else:
    return "No action taken."
    def get_status(self):
    return f"Status: {self.status}"

  • class AutomationTrigger:
    def __init__(self, threshold):
    self.threshold = threshold
    self.status = "inactive"

    def check_trigger(self, value):
    if value > self.threshold:
    self.status = "active"
    return "Automation triggered!"
    else:
    return "No action taken."
    def get_status(self):
    return f"Status: {self.status}"

  • class AutomationTrigger:
    def __init__(self, threshold):
    self.threshold = threshold
    self.status = "inactive"

    def check_trigger(self, value):
    if value > self.threshold:
    self.status = "active"
    return "Automation triggered!"
    else:
    return "No action taken."
    def get_status(self):
    return f"Status: {self.status}"

Step 3

Seamless Integration

We integrate automation into your existing infrastructure with minimal disruption.

Our solution

Your stack

Our solution

Your stack

Step 4

Continuous Workflow Optimisation

We refine performance, analyse insights, and enhance automation for long-term growth.

ICSR Processing Automation

Case processing time reduced by 70%

Regulatory Submission Tracker

Submission flow updated

Document Validation System

All required fields validated

ICSR Processing Automation

Case processing time reduced by 70%

Regulatory Submission Tracker

Submission flow updated

Document Validation System

All required fields validated

Benefits

The Key Benefits of Automation for Pharma Operations

Discover how automation streamlines compliance workflows, reduces operational workload, and drives efficiency across pharmacovigilance, regulatory, and clinical operations.

Increased Productivity

Automating manual processes like ICSR handling and document validations frees up your team to focus on strategic safety oversight and operational excellence.

Faster Regulatory Compliance

Automated validation checks and submission workflows ensure faster, error-free filings with health authorities — reducing compliance risks.

Data Security & Compliance

Automation workflows are designed with built-in security and compliance safeguards, ensuring sensitive data stays protected and ready at all times.

Operational Cost Reduction

Minimize resource-intensive tasks, cut manual data entry, and optimize team bandwidth — leading to significant cost savings in PV and Regulatory operations.

Real-Time Operational Insights

Gain visibility into workflow statuses, bottlenecks, and key compliance KPIs that update in real-time.

Scalable Workflow Automation

Scale your operations efficiently as workload increases — without increasing system complexity.

FAQs

We’ve Got the Answers You’re Looking For

Quick answers to your AI automation questions.

How can AI automation help my business?

Is AI automation difficult to integrate?

What industries can benefit from AI automation?

Do I need technical knowledge to use AI automation?

What kind of support do you offer?

How can AI automation help my business?

Is AI automation difficult to integrate?

What industries can benefit from AI automation?

Do I need technical knowledge to use AI automation?

What kind of support do you offer?

Get a Free Workflow Audit

Book your free call and see how automation can save time, cut errors, and keep your operations audit-ready.

2025

ExtractAI

© All right reserved

2025

ExtractAI

© All right reserved