Pharmaceutical Software Development Company

Clinical data sitting in spreadsheets across 12 sites. Regulatory submissions delayed because your systems can't produce the right audit trail. Field force training that takes 3 months to roll out.

We build custom pharmaceutical software that replaces manual, error-prone processes with digital systems designed for the regulatory environment you operate in.

Clinical trial management, drug tracking, and regulatory compliance systems built with 21 CFR Part 11 and GDPR in mind
HCP training platforms that cut field force onboarding from months to weeks
We built a pharma training platform that reduced onboarding time from 6 weeks to 10 days
100+ products shipped including healthcare and life sciences technology

Summary

RaftLabs builds custom pharmaceutical software — clinical trial management systems, drug serialization and tracking platforms, regulatory compliance tools (21 CFR Part 11, GDPR), patient management portals, and HCP training platforms — for pharma companies replacing manual, error-prone processes with digital systems. We deliver production-ready platforms in 12–16 weeks with audit trails and compliance documentation built in from the start.

21 CFR Part 11And GxP-aware architecture

US, EU, APACPharma businesses across markets served

100+Software products shipped

FixedCost delivery

Our pharmaceutical software development services

Pharmaceutical software has two requirements that most dev agencies struggle with: it has to work correctly every time, and it has to prove it worked correctly. Audit trails, electronic signatures, and validation documentation aren't optional. They're part of the product.

We've built a pharmaceutical training platform deployed to a field force across multiple markets, and patient monitoring systems with clinical-grade data handling. We understand the difference between building for speed and building for compliance -- and we know how to deliver both.

Clinical trial management software

Clinical trial data is high-stakes data. It 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 in 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.

What you get

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

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.

What you get

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

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--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.

What you get

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

Regulatory submission document management

Regulatory submission packages for FDA, EMA, PMDA, and other agencies are enormous, structured, and need to be correct. Documents get submitted in CTD format, with cross-references, metadata, and electronic submission requirements that differ by region.

Manual document management in shared drives creates version control nightmares and delays submissions. We build document management systems for regulatory affairs teams that enforce structure, track versions, and produce submission-ready packages.

What you get

CTD-structured document management with module and section tracking
Version control with change tracking and electronic approval workflows
Automatic formatting checks against agency-specific submission templates
eCTD compilation and validation tools for electronic submissions
Integration with electronic signatures and audit trail requirements

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

Patient management and remote monitoring platforms

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

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

What you get

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
HIPAA-compliant data storage with 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

Pharmacovigilance and safety data management

Adverse event reporting is a post-market obligation, not a nice-to-have. 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 -- and route them through a structured medical review and regulatory submission workflow.

What you get

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

Problems we solve in pharma

Clinical trial data collection still using paper case report forms requiring manual transcription

Field investigators complete paper CRFs at clinical sites, which are then manually keyed into a central database by data entry staff. Transcription errors introduce data quality issues that require source data verification to resolve -- adding weeks to data cleaning before a regulatory submission can be prepared. We build electronic data capture systems where investigators enter data directly into structured eCRF screens with validation rules, eliminating the transcription step and the errors it introduces.

Regulatory submission dossier assembly taking months of manual document collation

Regulatory affairs teams preparing an IND, NDA, or MAA dossier spend months locating documents across shared drives, version-controlling them manually, and assembling them into CTD format. Submission timelines slip because document readiness is tracked in spreadsheets with no automated status visibility. We build document management systems structured around the CTD module hierarchy, with version control, approval workflows, and submission package assembly built into the platform.

Pharmacovigilance adverse event tracking managed in fragmented systems with no automated signal detection

Adverse event reports arrive through multiple channels -- call centres, clinical sites, literature review, and spontaneous reports -- and get entered into separate systems with no automated aggregation. Signal detection relies on periodic manual review of case counts rather than automated pattern analysis across the full case database. We build pharmacovigilance platforms that consolidate adverse event intake, route cases through medical review workflows, and surface signals from aggregate data without manual case counting.

Supply chain temperature and chain-of-custody monitoring not integrated with batch record systems

Cold chain shipments are monitored through standalone temperature loggers that produce PDF reports requiring manual review. Excursion events are not automatically linked to the batch records for the affected product, making deviation investigation a time-consuming document-matching exercise. We connect temperature monitoring data to batch record systems so excursion events trigger automated deviation records with the batch, shipment, and temperature data pre-populated.

Salesforce and medical rep activity data not connected to prescribing pattern analysis

Medical rep call data -- which HCPs were visited, what was discussed, what materials were left -- sits in a CRM that is not connected to prescribing data from market research or dispensing databases. The commercial team cannot see whether rep activity is influencing prescribing behaviour in the target territory. We build analytics layers that connect rep activity records to prescribing data, enabling territory managers to allocate rep time based on impact rather than activity volume alone.

Quality management system running on disconnected paper-based processes that auditors flag each inspection

SOPs, training records, deviation reports, CAPA records, and change controls exist in separate filing systems -- some paper, some shared drive -- with no single view of quality system status. FDA or EMA inspectors arrive and the QA team spends days locating records and demonstrating compliance. We build electronic quality management systems where SOPs, training, deviations, CAPAs, and change controls are managed in one platform with audit-ready reports generated on demand.

How we work with pharma businesses

We document the regulatory framework your system needs to operate in -- 21 CFR Part 11, GxP, GDPR, HIPAA -- and identify the specific compliance requirements that affect the build. We map your existing systems, data flows, and the manual process we are replacing. Discovery produces a documented scope with compliance requirements called out explicitly, not a generic proposal.

What to ask any pharma software team

Compliance and validation

Does the system implement 21 CFR Part 11 audit trails with user identity and timestamps on every record change?
How are electronic signatures implemented and bound to user identity?
Do you provide system documentation that supports IQ/OQ/PQ validation?
How does the platform handle data integrity across concurrent users at multiple sites?

Integration and data

Can the platform integrate with Veeva, SAP, and existing EDC systems via API?
How is patient or subject data de-identified or pseudonymised in transit between systems?
What data residency options are available for EU and US regulatory requirements?

Delivery and ownership

Is the cost fixed before development starts, or billed by the hour?
Do you receive full source code ownership on delivery?
What is the typical delivery timeline for a regulatory document management or pharmacovigilance platform?

Pharmaceutical software development cost

Scope	Estimated range	Timeline
Regulatory document management
Regulatory document management	$35,000–$65,000	10–14 weeks
Pharmacovigilance reporting tool
Pharmacovigilance reporting tool	$40,000–$80,000	12–16 weeks
Clinical data collection platform
Clinical data collection platform	$50,000–$90,000	14–20 weeks
Full pharma operations platform
Full pharma operations platform	$150,000–$300,000+	9–18 months

Why pharma teams need purpose-built software

30%of clinical trial data is estimated to contain errors when captured manually

4months average delay to IND submission caused by data readiness issues

6xfaster field force onboarding with a digital training platform vs. classroom-based programmes

Frequently asked questions

: Yes. For systems that require FDA compliance under 21 CFR Part 11, we design with the specific technical controls the regulation requires: audit trails with timestamps and user identification, electronic signature implementation with identity binding, system access controls, and data integrity validation. We can also support the validation documentation (IQ/OQ/PQ) that GxP-regulated clients need. We're not a validation consultancy -- you'll need a qualified validation team to sign off -- but we build systems that are designed to pass.
: Yes. Our most direct reference is a pharmaceutical training platform we built for a global pharma company with a large field force. The platform delivered training content, tracked completions, and produced compliance certificates. We cut their field force onboarding time from 6 weeks to 10 days. We've also built patient monitoring systems with clinical-grade data handling and HIPAA-compliant architecture.
: We can integrate with SAP, Oracle, Veeva, and most systems that offer an API. For legacy systems without a modern API, we've built integration layers using batch file exchange, database connectors, and middleware. The integration approach depends on what your existing system supports. We scope the integration work as part of the discovery process.
: For systems handling patient data, we design with data minimisation, encryption at rest and in transit, role-based access controls, and full audit trails. We use compliant cloud hosting (AWS or Azure in appropriate regions) and ensure data residency requirements are met. We're not a legal or compliance firm and don't give compliance advice -- but we've built systems that passed their clients' HIPAA and GDPR reviews. We document our architecture decisions so your compliance team can review them.
: A focused build -- like an HCP training platform or an adverse event intake system -- typically takes 12--16 weeks from kickoff to go-live. Clinical trial management systems are more complex, typically 4--6 months for a full build. Systems that require validation documentation take longer because the documentation process runs alongside development. We agree on milestones at the start so you know what to expect at each stage.
: A focused first product -- like an HCP training platform or a regulatory document management system -- typically runs $30,000--$70,000. A full eClinical platform or pharmacovigilance system is more complex and typically runs $80,000--$200,000+. The cost depends on scope, compliance requirements, and integrations. We scope every project before pricing it. Fixed cost, agreed before development starts.

Let's talk about your project

Tell us what's not working in your business. We'll diagnose the problem and tell you exactly what it would take to fix it.