Pharmaceutical Software Development Company

1. 01

   Clinical trial management software

   Clinical trial data drives regulatory submissions. It affects drug approval timelines. It has to be accurate, auditable, and accessible across multiple sites and time zones.

   Most mid-size pharma companies run their trials across a mix of Excel, email, and paper case report forms. That works until it doesn't, and it stops working at the moment you need to file. We build eClinical systems that capture trial data at the source, enforce protocol compliance, and produce audit-ready outputs.

   • Electronic data capture (EDC) designed around your protocol
   • eCRF (electronic case report form) builder with validation rules
   • Site management with investigator and patient tracking
   • Adverse event logging with automated regulatory reporting triggers
   • Full audit trail with electronic signature support (21 CFR Part 11)
   • Data export in CDISC SDTM format for regulatory submission

   Best for

   • Pharma companies running trials where data is collected manually across sites
   • CROs managing multiple studies and needing a platform that handles both
   • Biotech startups preparing for IND or NDA submission and needing audit-ready data
2. 02

   Drug serialization and track-and-trace systems

   Drug serialization is no longer optional in most markets. DSCSA (US), FMD (EU), and similar regulations require unique identifiers on each saleable unit and the ability to trace any product from manufacturer to patient.

   We build serialization systems and track-and-trace platforms that generate, apply, and report unique identifiers across your supply chain. These connect to your existing ERP or manufacturing execution system and produce the EPCIS reports your trading partners and regulators require.

   • Unique identifier generation and aggregation (item, case, pallet)
   • Integration with packaging line equipment (printers, cameras, rejection systems)
   • EPCIS event reporting for DSCSA and FMD compliance
   • Wholesaler and distributor portal for product verification
   • Suspicious product alert management and investigation workflows
   • Integration with SAP, Oracle, and industry-specific manufacturing systems

   Best for

   • Pharmaceutical manufacturers building or upgrading serialization capability for DSCSA or FMD compliance
   • Generic drug manufacturers handling high-volume serialization on multiple production lines
   • CMOs managing serialization on behalf of multiple pharma clients
3. 03

   HCP training and field force enablement platforms

   Medical representatives need to learn complex clinical data, product positioning, and compliance rules before they talk to a single doctor. Traditional training, classroom sessions, printed manuals, in-person sign-offs, takes 6 to 10 weeks and doesn't scale.

   We built a pharmaceutical training platform for a global pharma company that cut field force onboarding from 6 weeks to 10 days. The platform delivers digital modules, competency assessments, and certification tracking, with a full audit trail for regulatory sign-off.

   • Mobile-first training modules with video, interactive content, and knowledge checks
   • Compliance training with e-signature confirmation and completion certificates
   • Role-based content delivery: reps see modules relevant to their territory and product line
   • Manager dashboards for tracking team completion and assessment scores
   • Integration with HR systems for user management and onboarding automation

   Best for

   • Pharma companies with large field forces and slow, manual training processes
   • Medical device companies with complex product portfolios and training requirements
   • CROs and research organisations needing protocol training at scale
4. 04

   Regulatory submission document management

   Regulatory submission packages for FDA, EMA, PMDA, and other agencies are large, structured, and market-specific. Documents use CTD modules, cross-references, metadata, and electronic submission standards that should remain under the control of regulatory specialists.

   Shared drives make it hard to see which version is current, who approved it, which market it belongs to, and whether a dossier section is ready for the next review. We create or integrate controlled workflows that make those states visible while maintained regulatory publishing tools continue to own specialist compilation and validation where appropriate.

   • CTD-structured document management with module and section tracking
   • Version control with change tracking and electronic approval workflows
   • Dossier status by document owner, approval state, target market, and submission
   • Checks defined and approved by the regulatory team before a document changes state
   • Integration with maintained eCTD publishing, validation, signature, and archive systems where required

   Best for

   • Pharma regulatory affairs teams managing multiple submissions across multiple markets
   • Biotech companies preparing first IND, NDA, or MAA filings
   • Companies managing post-approval CMC changes and annual reports across regions
5. 05

   Patient management and remote monitoring platforms

   Clinical trials and disease management programs that require patient monitoring face a real data challenge: patients aren't at the clinic. Their vital signs, symptom reports, and medication adherence data must be captured remotely and fed into clinical records.

   We've built remote patient monitoring platforms with medical-grade data handling, encrypted storage with HIPAA-grade access controls, and integration with clinical data systems. Patients use a mobile app. Clinicians see structured data in their dashboard.

   • Patient-facing mobile app for remote data entry and device sync
   • Medical device integration (Bluetooth vital sign monitors, CGMs, wearables)
   • Structured data capture mapped to clinical terminology (SNOMED, LOINC)
   • Clinician dashboard with alert rules and patient-level data review
   • Data storage with HIPAA-grade access controls, encryption, and full audit trail
   • Integration with EDC systems and electronic health records

   Best for

   • Clinical trials running decentralised or hybrid site models
   • Pharmaceutical companies running patient support programs with remote monitoring components
   • Digital therapeutics companies building an evidence base for FDA clearance
6. 06

   Pharmacovigilance and safety data management

   Adverse event reporting is a post-market obligation. Missing a report, submitting late, or producing an inaccurate CIOMS or MedWatch form can result in regulatory action.

   We build pharmacovigilance tools that capture adverse events from multiple sources: call centres, clinical sites, literature, and spontaneous reports. Each case routes through a structured medical review and regulatory submission workflow.

   • Multi-channel adverse event intake: web form, email-to-case, call centre integration
   • Medical review workflow with causality assessment and seriousness criteria
   • Automated regulatory submission file generation (CIOMS, MedWatch, E2B)
   • Signal detection and aggregate reporting tools
   • Integration with EudraVigilance, FDA FAERS, and regional safety databases

   Best for

   • Pharma companies scaling their pharmacovigilance operations beyond spreadsheet management
   • Biotech companies preparing for their first drug approval and post-market requirements
   • CROs providing pharmacovigilance services to multiple pharma clients

05 Track record

• 01

  We've seen your problem before

  Across dozens of industries, we recognise your situation fast, then frame the fix around your margin and your operations, not a generic template.
• 02

  We own the number, not the ticket

  We measure success the way you do: hours saved, revenue earned, margin recovered. We stay through launch and growth, so the result is ours to own.
• 03

  Serious businesses trust us

  Vodafone, T-Mobile, Cisco, Energia, Aldi, Nike. Building since 2015. Serious businesses keep coming back because we stay accountable long after launch.

• 01

  Remote patient monitoring software for pharma

• 02

  Intelligent Document Processing

  Extract structured data from regulatory submissions, clinical study reports, adverse event forms, and pharmacovigilance documents.

• 03

  Business Process Automation

  Automate submission workflows, label change management, PV case processing, and regulatory reporting.

• 04

  AI Agent Development

  Autonomous agents for literature surveillance, safety signal detection, and regulatory query response.

• 05

  Custom Software Development

  Custom eTMF, regulatory information management, and pharmacovigilance platforms built to your 21 CFR and EMA requirements.