Pharmaceutical & life sciences

Cut compliance overhead. Accelerate launches. Digitize your field force.

We build GxP-compliant pharma software in 12 weeks - LMS platforms, sales force automation, eCTD submission tools, and track-and-trace systems. Every product ships with audit trails, electronic signatures, and validation documentation from day one.

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10+

Pharma products

98%

Certification rate

GxP

Compliant

Overview

Your compliance burden is growing faster than your digital capability

Pharmaceutical software development at RaftLabs 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. Your validation documentation writes itself as the product is built - not as a scramble before an FDA inspection.

We bring 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

10+ pharmaceutical products shipped with GxP-compliant training platforms, sales force automation tools, eCTD submission systems, and supply chain track-and-trace software for global pharmaceutical companies, regional manufacturers, and biotech startups. 12 weeks is our default, not our stretch goal.

10+

Pharma products

98%

Certification rate

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 because validation documentation, audit trails, and electronic signature requirements create engineering overhead 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 take 12+ clicks to reach a training module and have zero mobile support, leaving 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 across disconnected manufacturing, distribution, and retail systems

05

Clinical trial data sits in siloed 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 in 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

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. Replaces 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. Cuts manual reconciliation between systems and accelerates database lock timelines.

06

AI-powered pharmacovigilance

NLP-driven 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 that cuts pharmacovigilance cycle times from weeks to days.

Use Cases

Real-world use cases

Compliance training 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 a 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.

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 for a regulatory affairs team

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 - cut 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.

Proof

How we've solved pharmaceutical & life sciences problems

Pharmaceutical

Training and engagement app for Eris Lifesciences

Mobile training and engagement platform for 5,000+ pharmaceutical field employees - 3,500 daily active users, 42% engagement increase, 25% training time reduction.

3,500+

Daily active users

30 minutes

Average daily usage

“Our field force went from dreading quarterly training workshops to spending 30 minutes a day on the app voluntarily. The gamification works, but the real win is having training, messaging, and field reporting in one place.”

Eris Lifesciences Training Lead, Head of Training & Development
Read case study

Our Approach

How we approach pharmaceutical & life sciences projects

1
Phase 1· Week 1-2

Compliance scoping and regulatory mapping

We map your regulatory requirements - FDA 21 CFR Part 11, EU Annex 11, CDSCO, GAMP 5 classification - before writing a line of code. Which system components require validation, the compliance framework, and the User Requirements Specification all get documented upfront.

Deliverables

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

Validated design and architecture

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

Deliverables

  • GxP-compliant system architecture with security controls
  • Functional Specification and Design Specification
  • Integration plan with existing enterprise systems
3
Phase 3· Week 4-10

Build with IQ/OQ protocols

We build in sprints and execute Installation Qualification and Operational Qualification protocols alongside development - not after. Each sprint validates that the built system meets its design specifications. This kills the 4-8 week post-build validation bottleneck that slows every pharma project.

Deliverables

  • Working product with IQ/OQ protocols executed per sprint
  • Traceability matrix linking URS, FS, DS, and test cases
  • Deviation reports and resolution documentation
4
Phase 4· Week 10-12

Rollout with CSV documentation

Performance Qualification in production, user acceptance testing with business owners, and complete Computer System Validation 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 with 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
Kills the 4-8 week post-build validation bottleneck through sprint-integrated IQ/OQ execution

Free Tools

Free tools for pharmaceutical & life sciences

Calculators and assessments built from real project data. No signup required.

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Pattern Transfer

RaftLabs 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. The engineering discipline transferred directly.

Services

Services for pharmaceutical & life sciences

Frequently asked questions

Projects 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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