What is pharma supply-chain software?

Platform managing pharmaceutical product movement-DSCSA EPCIS serialization, cold-chain monitoring, lot management, recall workflows, eBR, REMS compliance, and ERP/WMS integration-with 21 CFR Part 11 audit trails and IQ/OQ/PQ validation.

What is DSCSA and why does it require new software?

Drug Supply Chain Security Act requires interoperable EPCIS 2.0 track-and-trace by November 2025 for all pharmaceutical supply chain entities. Non-compliance risks FDA enforcement including product seizure.

How long does pharma supply-chain software development take?

Starter DSCSA: 14–18 weeks. Growth with cold-chain and ERP: 16–22 weeks. Enterprise with eBR and REMS: 20–28 weeks.

How much does pharma supply-chain software cost?

From $100K Starter with IQ/OQ/PQ, $150K–$200K Growth, $200K–$250K+ Enterprise-all fixed-price.

Does the platform include 21 CFR Part 11 validation?

Yes. Full IQ/OQ/PQ validation documentation-installation, operational, and performance qualification with traceability matrix-included in every tier.

Which cold-chain sensors do you integrate with?

Sensitech TempTale, DeltaTrak FlashLink, Berlinger Fridge-tag, and any sensor with REST or MQTT API-for 2–8°C, 15–25°C, -20°C, -80°C products.

Can the platform handle REMS compliance?

Yes. Patient enrollment, prescriber certification, dispensing authorization, monthly REMS assessment reports, and FDA REMS audit trail.

How does the fixed-price engagement work?

Scoped with supply chain workflow discovery. Proposal in 48 hours. Locked before any code is written. 70% extend to multi-year roadmaps.

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Pharma Supply-Chain Software Development in USA

Q: How do I get started?

Book a free 30-min strategy call with product portfolio, DSCSA compliance status, cold-chain requirements, ERP/WMS system, and any FDA inspection findings. Proposal within 48 hours.

Build DSCSA-compliant pharmaceutical supply-chain software-serialization, track-and-trace, cold-chain temperature monitoring, lot recall management, and FDA 21 CFR Part 11 audit trails-from $100K. Shipped for pharmaceutical manufacturers, wholesalers, specialty pharmacies, and 3PLs across New Jersey, Philadelphia, Chicago, and San Francisco.

Book a Free 30-min Strategy Call See Pharma Supply Chain Work

Pharma Supply-Chain Software Development in USA

97% Client Retention Rate

100+ products launched

04 Unicorns Shipped

USA · UK · KSA delivery

ISO & NDA Compliant

Trusted by category-defining companies across the USA, UK, India & the Middle East.

WHO IT'S FOR

How to Work With EngineerBabu on AI Agent Development

Your product stage defines your engagement model. We offer three ways to access our AI agent development services, from a single sprint to full end-to-end ownership.

VP of Supply Chain / CSCO (Pharmaceutical Manufacturer)

You're manufacturing prescription drugs and need DSCSA-compliant serialization-unique product identifiers (UPIs) at the saleable unit and case level, EPCIS event data generation for dispensing and shipping events, and trading partner verification response capability-by the FDA's 2025 interoperability deadline.

Get a free consultation

VP of Operations (Pharmaceutical Wholesaler / 3PL)

You're distributing pharmaceutical products and need a track-and-trace platform that receives EPCIS data from manufacturer trading partners,manages cold-chain temperature monitoring for controlled storage, and integrates with your warehouse management system (WMS) for lot-level inventory control.

Get a free consultation

CTO / Head of Technology (Specialty Pharmacy / Biotech)

You're dispensing specialty biologics and cell and gene therapies-with complex cold-chain requirements (2–8°C, -20°C, -80°C), REMS compliance documentation, and FDA 21 CFR Part 11 audit trail requirements for electronic batch records. You need a platform purpose-built for specialty product supply chain.

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Key Features

Built for Teams Shipping AI in Production

DSCSA Serialization & Track-and-Trace

Unique product identifier (UPI) generation and management at saleable unit, homogeneous case, and lot level-with EPCIS event generation (commissioning, packing, shipping, receiving, dispensing) compliant with GS1 standards and FDA DSCSA requirements.

Trading Partner Data Exchange (EPCIS)

EPCIS 2.0 data exchange with upstream (manufacturer) and downstream (wholesaler, dispenser) trading partners-supporting verification response service (VRS) queries, product tracing requests, and suspect product investigation workflows.

Cold-Chain Temperature Monitoring

Real-time IoT temperature sensor integration (Sensitech, Berlinger, DeltaTrak)-monitoring cold-chain integrity from manufacturer through distribution to dispensing, with excursion alerting, temperature deviation documentation, and FDA 21 CFR Part 211 storage records.

Lot &Batch Management

Full lot lifecycle management, raw material lot tracking, FEFO picking logic for warehouse operations. Without end-to-end traceability built into every transaction, a single expiry oversight or mispicked batch isn't just an operational error; it's a potential FDA finding.

Recall & Quarantine Management

Automated lot-level recall execution affected lot identification, quarantine workflow. When a recall is triggered, every missed trading partner notification, they're auditing whether your recall execution process was fast.

Electronic Batch Records (eBR)

21 CFR Part 11-compliant electronic batch records-capturing manufacturing steps, in-process testing, deviations, CAPA linkage, and batch disposition-replacing paper batch records with searchable, audit-ready digital records.

REMS Compliance Documentation

Risk Evaluation & Mitigation Strategy compliance tracking for specialty drug programs patient enrollment. A missed prescriber certification or an undocumented dispensing isn't a paperwork gap; patient access to the specialty drugs program exists to deliver.

ERP & WMS Integration

Bidirectional integration with SAP S/4HANA, Oracle ERP, Manhattan WMS, and Blue Yonder-syncing lot data, inventory positions, purchase orders, and shipment events between the pharma supply chain platform and existing enterprise systems.

Want one of these live in 8 weeks?

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AI AGENT SOLUTIONS

Types of Pharmacy Supply chain You Can Build With Us

DSCSA Compliance Platform

A purpose-built DSCSA serialization and track-and-trace platform-UPI generation, EPCIS event management, trading partner data exchange, and verification response service-for pharmaceutical manufacturers, wholesalers, and dispensers meeting FDA's 2025 interoperability mandate. Best for: Any entity in the US pharmaceutical distribution chain subject to DSCSA.

Cold-Chain Monitoring & Compliance Platform

A real-time cold-chain temperature monitoring platform-IoT sensor integration across distribution network, excursion alerting, temperature deviation documentation, and FDA 21 CFR Part 211 storage record generation for temperature-sensitive pharmaceuticals and biologics. Best for: Biotech/biopharma cold-chain products, vaccine distributors, specialty pharmacy cold-chain operations.

Specialty Pharmacy Supply Chain Platform

A platform for specialty pharmacy operations-patient-specific lot tracking, REMS compliance management, specialty product receiving and dispensing workflows, temperature-sensitive product handling, and hub and specialty pharmacy coordination. Best for: Specialty pharmacies, hub services, specialty distribution, cell and gene therapy logistics.

Pharmaceutical 3PL Technology Platform

A technology platform for pharmaceutical 3PLs-multi-client lot management, DSCSA-compliant track-and-trace across client products, cold-chain monitoring, client-facing inventory portals, and FDA-ready audit trail management. Best for: Pharmaceutical 3PL operators, specialty distribution companies, cold-chain logistics providers.

Electronic Batch Record & Quality Management System

A 21 CFR Part 11-compliant eBR and QMS platform-electronic batch records, deviation management, CAPA workflows, change control, supplier qualification, and batch disposition-replacing paper-based GMP documentation. Best for: Pharmaceutical manufacturers, contract manufacturers (CMOs), API producers.

Cold-Chain Monitoring & Compliance Platform

Specialty Pharmacy Supply Chain Platform

Electronic Batch Record & Quality Management System

Not sure which agent fits your workflow?

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Trusted by Industry Leaders

LLMs & Foundation Models We've Worked With

We're proud to have partnered with top VC-backed companies, helping them achieve their growth milestones.

GPT-4o

Anthropic Claude 3.5 Sonnet

Mistral Large

Google Gemini 1.5

Cohere Command R+

Meta Llama 3

Agent Frameworks We've Worked With

We're proud to have partnered with top VC-backed companies, helping them achieve their growth milestones.

LangChain

LangGraph

CrewAI

LlamaIndex

AutoGen

Semantic Kernel

Agent Frameworks We've Worked With

We're proud to have partnered with top VC-backed companies, helping them achieve their growth milestones.

Pinecone

Weaviate

pgvector

Qdrant

Elasticsearch

Mongo Atlas Vector

Agent Frameworks We've Worked With

We're proud to have partnered with top VC-backed companies, helping them achieve their growth milestones.

AWS · Bedrock

Google Cloud

Azure OpenAI

Kubernetes + Terraform

Vercel · Modal

LangSmith + Datadog

Pricing

Built for Teams Shipping AI in Production

$100K-$150K /month

(14-18 weeks)

Starter

Best for: DSCSA compliance deadline, single product line, manufacturer or wholesaler

DSCSA serialization engine (UPI generation, EPCIS events)
Trading partner data exchange (EPCIS 2.0)
Basic lot tracking and inventory management
21 CFR Part 11 audit trail
1 ERP integration (SAP or Oracle)
IQ/OQ/PQ validation documentation
30-day post-launch support + IP ownership

A Process Designed for Outcomes

We follow a transparent, collaborative process, from discovery to deployment. Designed to help founders move fast, stay lean, and build reliable, scalable products.

Supply Chain Workflow Discovery & Compliance Scoping

Map the pharmaceutical supply chain-product types, distribution network, trading partners, DSCSA obligations, cold-chain requirements, and ERP/WMS integration points. Deliverable: Supply chain flow diagrams, DSCSA compliance obligations inventory, cold-chain sensor specification, ERP integration scope.

21 CFR Part 11 Architecture & Infrastructure

Design 21 CFR Part 11 technical controls electronic records, configure compliant cloud infrastructure with residency requirements. This foundation determines whether every electronic record your platform generates is FDA-defensible from day one audit trails and controls built in at the architecture layer are exponentially cheaper.

Core Platform Build & Lot Tracking

Build serialization engine, EPCIS event management, lot tracking, and with 21 CFR Part 11 audit trails active throughout. This is the step where compliance architecture becomes a functioning system for every serialized unit, your validation environment reflects exactly what regulators will inspect in production.

Cold-Chain Integration & Trading Partner Exchange

Build IoT temperature sensor integrations, excursion alerting, and EPCIS trading partner data exchange-tested against manufacturer and wholesaler sandbox environments. Deliverable: Cold-chain dashboard with live sensor data, EPCIS exchange tested with 2 trading partner types.

ERP / WMS Integration & Recall Management

Build SAP/Oracle ERP and WMS bidirectional integration, lot recall execution workflow, FDA notification documentation. A recall workflow not deeply integrated with your ERP, where every system that doesn't automatically sync adds critical lag between a recall trigger.

System Validation (IQ/OQ/PQ) & Go-Live

Execute IQ/OQ/PQ validation, produce FDA-ready documentation, phased production go-live starting with a single product line. IQ/OQ/PQ validation package, pilot product line live on production. The phased single-product-line go-live isn't a limitation; it's a deliberate strategy.

Aanchal Chaurasia Director, EngineerBabu

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CASE STUDIES

What We’ve Built With Leaders and CXOs

Bank Open Neobank Platform

Bengaluru

Google x EngineerBabu AI Based Hackthon Assessment

India

Airbox E-commerce Marketplace

Singapore

Chhattisgarh PoliceSummons & Warrant Management

India

Shule Direct Ed Tech Platform

East Africa

Invulb Wealth Management App

India

Framebazaar E-commerce Platform

India

LumiereB2B Healthcare Marketplace

Singapore

ShoppiGrocery Delivery App

Africa

AskMeEdTech App

India

BURQ Custom Logistics Platform

USA

Supersourcing AI-Powered Hiring Platform

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Digital Training Platform Baxolile Mabinya

Deviare Digital Training Platform

South Africa

Delivery Management Platform Deepak Verma

Delivr Delivery Management Platform

UAE

Rx Agile Trainer-First Learning Platform

Bengaluru

Nigerian Air Force Process Automation Platform

Africa

Butterfly Social Discovery App

Switzerland

Why Us

Why EngineerBabu?

We sign strict NDAs, ensure full IP ownership, and follow ISO-certified processes. With dedicated development teams, flexible engagement models, and 24/7 support, we are a trusted CMMI level 5 hybrid app development company committed to quality and on-time delivery.

1250+ Projects Delivered

1000+ Happy Clients

170+ Expert Talent

Transparent Pricing

Proven Expertise

Top-notch IT Solutions

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Backed by Industry Leaders and Certifications

Featured in Google for Startups AI Accelerator and recognized by LinkedIn as a Top Startup.

AI ACCELERATOR TOP 20 STARTUPS 2024

Top 20 Indian Startups 2023 & 2024

Highly rated on Clutch with an impressive 4.9★!

Proudly showcased in the Google for Startups AI Accelerator and celebrated by LinkedIn as a Top Startup!

Regulatory Compliance, Built Into Every Layer

Our Mortgage App Development Services are designed with regulatory compliance at the core. From PCI DSS and PSD2 to GDPR, AML/KYC, CCPA, and Open Banking standards, we embed audit-ready controls directly into your platform architecture.

Honest feedbacks

Stories From Founders Who’ve Worked With Us

Harshit Thareja Co-Founder

Singapore

Anish AchuthanCEO & Co-Founder

Bengaluru

Bhavna GuptaIPS Officer

Chhattisgarh

Danny SchwartzFounder & CEO

United States

Adam Faanes CTO & Co-Founder

New York

Andile NgcabaChairman & Founder

South Africa

Lakshmikant SinghFounder & CEO

India

Baxolile Mabinya Co-Founder

South Africa

Analyzing the Competition

Agencies Deliver Projects, We Deliver Growth.

Offshore Body-Shop

Freelancer / Local Studio

Entry price

NDA + IP transfer pre-discovery

Design-led product thinking

Senior AI engineers on every project

Code, prompts & weights ownership

Post-launch SLA

Founder / CTO access

Weekly demos

US-timezone overlap

From $100K (custom, validated, IP yours)

GS1/EPCIS 2.0 compliant, FDA-ready

Full IQ/OQ/PQ validation docs included

Sensitech, DeltaTrak, Berlinger-built in

SAP S/4HANA + Oracle ERP-deep integration

100% yours, contractually

Fully custom-your supply chain model

Every sprint, without asking

Full PT-ET coverage daily

$40K–$80K (no pharma expertise)

Not available

Basic API

Often retained

Template-based

Monthly at best

2-4 hrs

$200K–$1M+ licensing

Vendor-certified

Vendor-validated

Separate module

Standard connectors

Vendor owns

Limited by vendor

N/A

US-based

US DELIVERY COVERAGE

Trusted by Pharma Supply Chain Teams Across the USA

EngineerBabu has built pharmaceutical supply-chain software for pharmaceutical manufacturers, specialty pharmacies, 3PLs, wholesalers, and biotech companies across every major US pharma market. Whether you're meeting DSCSA interoperability requirements in New Jersey, building a specialty pharmacy cold-chain platform in Chicago, deploying a 3PL track-and-trace system in Philadelphia, or building electronic batch records for a manufacturer in San Francisco-we've shipped in your supply chain model and against your FDA compliance requirements.

We serve clients across New Jersey · Philadelphia · Chicago · San Francisco · Boston · New York · Los Angeles · Research Triangle · Houston · Indianapolis-with full PT–ET timezone alignment and same-day response across all US pharma markets.

From the pharmaceutical manufacturing corridors of New Jersey and Philadelphia to the biotech hubs of Boston and San Francisco, and the specialty distribution networks of Chicago and Indianapolis-pharma supply-chain software in the USA demands DSCSA/EPCIS expertise, 21 CFR Part 11 validation depth, cold-chain IoT integration, and a development team that has delivered validated supply-chain software into FDA-inspected pharmaceutical environments.

Get a Free Consultation

Mayank Pratap Singh Founder, EngineerBabu

Supporting AI Teams Across the United States

FAQs

Frequently Asked Questions

A digital platform managing pharmaceutical product movement from manufacturer to patient-DSCSA-compliant serialization and EPCIS track-and-trace, cold-chain temperature monitoring, lot management, recall workflows, electronic batch records, REMS compliance, and ERP/WMS integration-with 21 CFR Part 11 compliant audit trails and IQ/OQ/PQ validation.

The Drug Supply Chain Security Act (DSCSA) requires all pharmaceutical manufacturers, wholesalers, dispensers, and repackagers to implement interoperable electronic track-and-trace systems by November 2025-exchanging product tracing information using EPCIS 2.0 standards with trading partners. Companies that don't meet the interoperability requirement face FDA enforcement action including product seizure.

Starter DSCSA compliance platforms: 14–18 weeks. Growth full supply-chain platforms with cold-chain and ERP integration: 16–22 weeks. Enterprise multi-product platforms with eBR and REMS: 20–28 weeks.

From $100K for a Starter DSCSA compliance platform with IQ/OQ/PQ documentation, $150K–$200K for a Growth full platform with cold-chain and WMS integration, and $200K–$250K+ for an Enterprise multi-product platform with eBR and REMS-all fixed-price.

Yes. IQ/OQ/PQ validation documentation is included in every tier-covering installation qualification, operational qualification, and performance qualification with traceability matrix and validation summary report. This is the FDA-required validation package for regulated pharmaceutical software.

Sensitech TempTale, DeltaTrak FlashLink, Berlinger Fridge-tag, and any sensor with a REST or MQTT API-monitoring temperature at warehouse, distribution center, and shipment level with configurable excursion thresholds per product storage requirement (2–8°C, 15–25°C, -20°C, -80°C).

Yes. REMS compliance management-patient enrollment tracking, prescriber certification verification, dispensing authorization, monthly/quarterly REMS assessment report generation, and FDA REMS program audit trail-for specialty drug programs with FDA-mandated REMS requirements.

SAP S/4HANA, Oracle ERP Cloud, Microsoft Dynamics 365, Manhattan Associates WMS, Blue Yonder (JDA), and any ERP/WMS with a REST or EDI API. Deep SAP and Oracle integration experience including GS1 article master data sync.

Scoped in a free 30-min strategy call including supply chain workflow discovery. Written proposal in 48 hours. Scope, price, and timeline locked before any code is written. 70% of clients extend into multi-year supply chain roadmaps.

Book a free 30-min strategy call. Bring your product portfolio, DSCSA compliance status, cold-chain requirements, ERP/WMS system, and any pending FDA inspection findings related to supply chain. Scoped proposal within 48 hours.