Regulatory Intelligence for Global Pharma

AI-Driven Pharma
Platform & Solutions

Transforming global regulatory data into predictive compliance intelligence for confident drug and device approvals.

Working with Global Pharma Manufacuring Companies

PharmaRegAI

Pharma Regulatory Intelligence

Structured FDA 483 intelligence enhanced by expert-validated root cause and CAPA insights with AI-powered navigation.

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483 Intelligence

Structured FDA 483 and global inspection documents with powerful search across investigators, systems, companies, and years.

Transparency

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483 Intelligence

Structured FDA 483 and global inspection documents with powerful search across investigators, systems, companies, and years.

Transparency

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Validated RC and CaPa

Expert-written and ex-FDA–approved root cause and CAPA insights revealing real compliance failures and systemic weaknesses.

Credibility

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AI-Enabled SaaS

Enterprise SaaS platform with AI-powered document understanding, compliance dashboards, and scalable secure deployment options.

Scalability

10

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483 PDFs

500

+ hrs

Research Time Eliminated

70%

AI Insights

AI & Custom Software Services of Pharma

AI-Driven Compliance: Predictive regulatory intelligence

Custom Software Solutions: Optimise day to day operations.

Data-driven Systems

Turn raw data into actionable insights that smarter decisions and measurable growth.

Custom Software

Work smarter, not harder. Unlock faster results with customised solution as per your requirements.

Workflow & Process Automation.

We deploy RPA-driven automation to eliminate repetitive manual tasks such as data entry, Excel extraction, OCR-based document processing, reducing human error, accelerating workflows, and improving operational efficiency across pharma manufacturing systems.

Custom On-Premise AI Solutions

Design and deploy custom AI software and domain-specific models trained on your internal data, securely hosted within your infrastructure to ensure compliance, data privacy, and enterprise-grade control.

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Enterprise Application & Solutions

Develop AI-powered chatbots, virtual assistants, FDA validation agents, and SaaS or ERP systems embedded with intelligence to streamline submissions, automate compliance checks, and enhance decision-making across pharma operations.

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COMPARISION

Why Choose Us

We help businesses harness the power of AI to work smarter, scale faster, and innovate boldly using custom automation & solutions.

PharmaRegAI

Built specifically for drug & device manufacturing compliance environments.

Built specifically for drug & device manufacturing compliance environments.

Expert-written and ex-FDA–validated root cause and CAPA intelligence.

Expert-written and ex-FDA–validated root cause and CAPA intelligence.

10,000+ structured inspection documents converted into actionable compliance intelligence.

10,000+ structured inspection documents converted into actionable compliance intelligence.

We can develop custom AI models trained on your internal data, deployable on-premise or secure cloud.

We can develop custom AI models trained on your internal data, deployable on-premise or secure cloud.

Designed to reduce inspection risk, protect approvals, and improve regulatory predictability.

Designed to reduce inspection risk, protect approvals, and improve regulatory predictability.

Others

Generic software vendors with limited GMP and inspection depth.

Generic software vendors with limited GMP and inspection depth.

AI-generated summaries or checklist-based interpretations without regulatory validation.

AI-generated summaries or checklist-based interpretations without regulatory validation.

Basic & unstructured document repositories or fragmented public data access.

Basic & unstructured document repositories or fragmented public data access.

Uses Cloud based One-size-fits-all SaaS tools with limited customization or data control.

Uses Cloud based One-size-fits-all SaaS tools with limited customization or data control.

Focused on workflow tracking rather than predictive regulatory risk reduction.

Focused on workflow tracking rather than predictive regulatory risk reduction.

INTEGRATIONS

Seamless AI Integrations That Work Everywhere

We integrate powerful AI tools directly into your existing platforms, enabling you to automate tasks, ensure your operations run seamlessly.

"Connect with 100's of apps without leaving the site"

PRICING

Pricing plans

Flexible pricing designed for pharma manufacturers, based on platform access, data intelligence modules, and enterprise customization needs.

Elite

Yearly Subscription

This plan includes

Actual FDA 483 PDFs

Company insights

Unlimited Downloads

Unlimited searches

Signature

Yearly Subscription

Everything in Elite plan

Individual Observation Summary

AI Insights for each Observation

Access to SaaS

Unlimited SaaS search & filters

Crown

Popular

Yearly Subscription

Everything in Signature plan

Root Cause for each observations

CAPA / observation

AI features

First access to latest features

Scalable plans for your regulatory and operational requirements.

Questions answered

We’re here to help you and solve objections. Find answers to the most common questions below.

What is PharmaRegAI?

What type of regulatory data does PharmaRegAI provide?

Are root cause and CAPA insights generated by AI?

How does AI help within the platform?

Who should use PharmaRegAI?

Can PharmaRegAI integrate with our internal systems?

Do you offer custom AI or software development services?

Can AI solutions be deployed on our premises?

What is PharmaRegAI?

What type of regulatory data does PharmaRegAI provide?

Are root cause and CAPA insights generated by AI?

How does AI help within the platform?

Who should use PharmaRegAI?

Can PharmaRegAI integrate with our internal systems?

Do you offer custom AI or software development services?

Can AI solutions be deployed on our premises?

mail us for any enquiries : sales@pharmaregai.com

Strategy & Content Creation

AI Consulting & Solutions

We design custom SaaS & AI solutions that drives growth.

After

Before

After

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Document & SoP creation

Leverage AI to create engaging, personalized documents.

What you still waiting!!

Start transforming regulatory complexity into clear, actionable intelligence. Strengthen inspection readiness and build a more confident compliance future today.

Inspection Readiness

Compliance Confidence