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Pharmaceutical & Life Sciences

Cut compliance costs. Accelerate drug launches. Digitize your field force.

We build GxP-compliant software for pharmaceutical companies - training platforms, sales force automation, compliance systems, and supply chain tools. Every product ships with audit trails, electronic signatures, and validation documentation from day one.

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98%

Certification rate

GxP

Compliant

Overview

Your compliance burden is growing faster than your digital capability

Pharmaceutical software development at 1Raft is compliance-first engineering. We bring validation patterns from 100+ products across healthcare, fintech, and other regulated industries to build GxP-compliant training platforms, sales force automation tools, eCTD submission systems, and supply chain serialization software - each engineered to pass FDA 21 CFR Part 11, CDSCO, and EU Annex 11 requirements while cutting the compliance overhead that slows every pharma technology initiative.

The pharmaceutical industry runs on regulation. Every system that touches patient data, drug manufacturing, or sales activity must meet GxP standards - FDA 21 CFR Part 11, CDSCO eCTD mandates, EU Annex 11, and GAMP 5 frameworks. Most pharma companies spend 15-20% of every software budget just on compliance overhead.

We build software that treats compliance as architecture, not an afterthought. Audit trails, electronic signatures, role-based access, and data integrity controls are baked into the foundation. This means your validation documentation writes itself as the product is built - not as a scramble before an FDA inspection.

1Raft brings patterns from 100+ shipped products to pharma-specific challenges: field force automation for 200K+ medical representatives still reporting on paper, training platforms for global sales teams managing country-specific regulations, and supply chain serialization tools for DSCSA compliance.

Experience Signal

1Raft builds GxP-compliant training platforms, sales force automation tools, compliance systems, and supply chain software for pharmaceutical companies. Our engineering draws on validation patterns proven across 100+ products in healthcare, fintech, and other regulated industries.

98%

Certification rate

GxP

Compliant

See case study

Industry Pain Points

What's broken in pharmaceutical & life sciences

01

GxP compliance adds 15-20% to every software project and delays launches by months - validation documentation, audit trails, and electronic signature requirements create engineering overhead that general-purpose dev shops don't anticipate

02

Field force teams across India's 200K+ medical representatives still track doctor visits, sample distribution, and prescription data through paper forms and WhatsApp groups - costing pharma companies visibility into their largest expense line

03

Legacy LMS platforms require 12+ clicks to reach a training module and have zero mobile support, resulting in 14% of sales reps carrying lapsed compliance certifications at any given time

04

DSCSA and India's track-and-trace mandates require serialization at the unit level, but most pharma supply chains still run on batch-level tracking with disconnected systems across manufacturing, distribution, and retail

05

Clinical trial data sits in siloed systems - CTMS, EDC, LIMS, and pharmacovigilance databases that don't talk to each other, creating manual reconciliation overhead and delayed signal detection

06

Manufacturing sites operate independent quality management systems with no real-time visibility across plants, making cross-site deviation trending and CAPA tracking impossible without manual consolidation

Solutions

Problems we solve in pharmaceutical & life sciences

Each solution is built from patterns we've validated across 100+ products. No experiments on your budget.

01

GxP-Compliant Platform Engineering

We build software with FDA 21 CFR Part 11 and EU Annex 11 compliance built into the architecture. Audit trails, electronic signatures, data integrity controls, and role-based access are foundational - not bolted on before an inspection. Validation documentation generates alongside the product.

02

Pharma LMS and Training Platforms

Mobile-first training platforms with bite-sized modules, scenario-based assessments, and country-specific compliance mapping. Automated certification tracking with escalating reminders. Offline support for field teams. Built to replace legacy enterprise LMS platforms that reps refuse to use.

03

Sales Force Automation (SFA)

Real-time field reporting for medical representatives - doctor visit logging, sample tracking, prescription data capture, and route optimization. GPS-verified visits, offline-first mobile architecture, and integration with existing CRM and ERP systems. Replace paper-based MR reporting entirely.

04

Supply Chain Track-and-Trace

Unit-level serialization for DSCSA and India track-and-trace compliance. End-to-end visibility from manufacturing through distribution to retail. Integration with existing ERP and warehouse management systems. Real-time alerts for diverted or expired products.

05

Clinical Trial Management

Unified platforms connecting CTMS, EDC, and safety databases. Automated protocol deviation detection, patient recruitment optimization, and site performance dashboards. Reduce manual reconciliation between systems and accelerate database lock timelines.

06

AI-Powered Pharmacovigilance

NLP-powered adverse event detection from structured and unstructured sources - medical literature, social media, call center transcripts, and clinical databases. Automated case intake, signal detection, and regulatory reporting to reduce pharmacovigilance cycle times from weeks to days.

Use Cases

Real-world use cases

Compliance Training Platform for 4,200 Global Sales Reps

Problem

A global pharmaceutical company's sales training relied on in-person workshops costing $2.8M annually. Compliance certifications varied across 11 countries, and 14% of reps had lapsed certifications at any given time because the legacy LMS was unusable on mobile.

What we built

We built a mobile-first training platform with 5-8 minute bite-sized modules, scenario-based assessments, country-specific compliance mapping, offline support, and automated certification tracking with escalating reminders to managers for overdue certs.

Result

On-time certification completion reached 98%. Training costs dropped 72%. Lapsed certifications fell from 14% to under 2%. Average module completion time was 6.2 minutes, fitting between client meetings.

Field Force Automation for Regional Pharma Company

Problem

A mid-size Indian pharma company with 800+ medical representatives tracked doctor visits through paper daily call reports. Managers had no real-time visibility into field activity, sample inventory was reconciled monthly, and territory optimization relied on gut feel rather than data.

What we built

We built a mobile-first SFA with GPS-verified visit logging, real-time sample tracking, prescription data capture, and AI-powered route optimization. Offline-first architecture meant reps in rural areas could sync when connectivity returned.

Result

Daily call report completion went from 62% to 97%. Sample reconciliation moved from monthly to real-time. Territory coverage optimization identified 23% more high-potential doctors per route. Manager dashboards replaced weekly Excel compilations.

eCTD Submission Automation Tool

Problem

A pharma company's regulatory affairs team spent 6-8 weeks manually assembling eCTD submissions for CDSCO - cross-referencing documents, validating formats, and creating submission sequences. Each revision cycle added 2-3 weeks.

What we built

We built an automated eCTD assembly tool that ingests regulatory documents, validates against ICH CTD structure, generates submission sequences, and flags missing sections. Template-based assembly for common submission types (NDA, ANDA, variations) reduced manual effort by 70%.

Result

Submission assembly time dropped from 6-8 weeks to under 2 weeks. Validation errors caught before submission eliminated 85% of CDSCO rejection cycles. The regulatory affairs team redirected time to strategy instead of document assembly.

Cross-Site Quality Management Dashboard

Problem

A multi-site manufacturer operated independent quality management systems across 4 plants. Deviation trending, CAPA tracking, and batch release decisions required manual data consolidation from each site - a process that took 3-5 days per monthly review cycle.

What we built

We built a unified quality dashboard pulling real-time data from each site's QMS. Automated deviation trending across sites, CAPA status tracking with escalation workflows, and batch release dashboards with integrated electronic signatures for authorized quality personnel.

Result

Monthly quality review preparation went from 5 days to same-day. Cross-site deviation patterns that previously went undetected were identified within 48 hours. Batch release cycle time shortened by 40%.

Our Approach

How we approach pharmaceutical & life sciences projects

1
Phase 1· Weeks 1-3

Compliance Scoping and Regulatory Mapping

We map your regulatory requirements - FDA 21 CFR Part 11, EU Annex 11, CDSCO requirements, GAMP 5 classification - before writing a line of code. We identify which system components require validation, define the compliance framework, and document the User Requirements Specification (URS).

Deliverables

  • Regulatory requirements matrix (FDA, CDSCO, EU Annex 11, country-specific)
  • GAMP 5 software categorization and risk assessment
  • User Requirements Specification (URS) with traceability matrix
2
Phase 2· Weeks 4-5

Validated Design and Architecture

Architecture designed for compliance - audit trails, electronic signatures, role-based access, data integrity controls. We produce the Functional Specification (FS) and Design Specification (DS) with full traceability back to the URS. Integration points with existing systems (ERP, CRM, LIMS) are mapped and validated.

Deliverables

  • GxP-compliant system architecture with security controls
  • Functional Specification (FS) and Design Specification (DS)
  • Integration plan with existing enterprise systems
3
Phase 3· Weeks 6-12

Build with IQ/OQ Protocols

We build in sprints and execute Installation Qualification (IQ) and Operational Qualification (OQ) protocols alongside development - not after. Each sprint validates that the built system meets its design specifications. This eliminates the 4-8 week post-build validation bottleneck that plagues pharma projects.

Deliverables

  • Working product with IQ/OQ protocols executed per sprint
  • Traceability matrix linking URS → FS → DS → test cases
  • Deviation reports and resolution documentation
4
Phase 4· Weeks 13-16

Rollout with CSV Documentation

Performance Qualification (PQ) in production, user acceptance testing with business owners, and complete Computer System Validation (CSV) documentation package. We hand off a system that's audit-ready from day one - not one that needs months of remediation before an inspector arrives.

Deliverables

  • Complete CSV documentation package (validation summary report)
  • PQ execution with production data
  • Training documentation and standard operating procedures

Outcomes

Measurable outcomes

72% reduction in compliance training costs through mobile-first digital delivery replacing in-person workshops
98% on-time certification completion across global sales teams with automated tracking and escalation
70% faster eCTD submission assembly through automated document validation and template-based generation
Real-time field force visibility replacing paper-based MR reporting with GPS-verified digital logs
40% shorter batch release cycles through unified cross-site quality dashboards with electronic signatures
Elimination of the 4-8 week post-build validation bottleneck through sprint-integrated IQ/OQ execution

Pattern Transfer

1Raft built HIPAA-compliant patient engagement platforms and clinical documentation tools for healthcare before applying the same compliance-first architecture to pharma. Both industries require audit trails, electronic signatures, and validated systems - the regulatory framework changed from HIPAA to GxP, but the engineering discipline transferred directly.

Services

Services for pharmaceutical & life sciences

Proof

Pharmaceutical & Life SciencesPharma Sales Team Training & Certification Platform
4,200+

Sales reps trained

12

Weeks to launch

Read case study

Frequently asked questions

Projects typically range from $80K-$250K depending on scope. GxP compliance adds 15-20% to a standard build for audit trails, electronic signatures, validation documentation, and IQ/OQ/PQ protocols. We include this in every estimate. The alternative - building first and retrofitting compliance - costs 3-4x more and delays launch by months.

Next Step

Every month without validated digital systems is another month your compliance team spends on manual documentation.

One call with a founder. No sales team, no follow-up sequence. If we can't help, we'll say so.

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