Custom software for pharmaceutical companies, biotech firms, and CROs that need clinical data platforms, regulatory document management, and pharmacovigilance systems built with compliance requirements in mind from the first sprint -- not added after a regulatory review finds gaps.
Generic platforms do not handle GxP audit trails, 21 CFR Part 11 electronic signatures, or CTD submission structure. We build pharma software where the compliance requirements are part of the architecture, not a layer added at the end.
Clinical trial data platforms -- eCRF, site monitoring, and audit-ready data export built for regulatory submission
Regulatory document management with 21 CFR Part 11 electronic signatures, version control, and CTD structure
Pharmacovigilance and adverse event reporting systems with automated regulatory filing triggers
AI-assisted document tools for regulatory drafting, molecule screening support, and clinical data review
Summary
RaftLabs builds custom pharmaceutical software for pharma companies, biotech firms, and CROs -- clinical trial data management platforms, regulatory submission and document management systems, pharmacovigilance and adverse event reporting tools, drug serialisation compliance software, LIMS integrations, and AI-assisted document workflows. All pharma software is built with GxP validation requirements in mind from the start.
Pharmaceutical software has two requirements that most development teams underestimate. First, it has to produce correct data every time. Second, it has to prove it produced correct data -- with an audit trail, an electronic signature, and validation documentation that a regulator can review.
When those requirements are added after development, the cost of rework is high and the delay to submission is real. We design GxP requirements into the software architecture from the start. Audit trails built in. Electronic signatures implemented to 21 CFR Part 11. Validation documentation produced alongside development. The result is a system that your validation team can qualify without rebuilding.
Electronic data capture platforms built around your protocol -- eCRF design with validation rules, edit checks, and required field enforcement. Site management with investigator and patient tracking across multiple trial sites. Adverse event logging with automatic regulatory reporting triggers. Data export in CDISC SDTM and ADaM formats for FDA and EMA submissions. Full audit trail with timestamps and user identification on every data entry and change.
Document management for regulatory affairs teams built around CTD module structure. Version control with electronic approval workflows and change tracking. Automated formatting checks against FDA, EMA, and PMDA submission templates. eCTD compilation and validation tools. Electronic signatures implemented to 21 CFR Part 11 requirements. Submission-ready document packages produced without manual collation from shared drives.
Multi-channel adverse event intake -- web forms, email-to-case, and call centre integration. Medical review workflows with causality assessment, seriousness criteria, and case narrative generation. Automated regulatory submission file generation in CIOMS, MedWatch, and E2B(R3) formats. Signal detection and aggregate reporting. Integration with EudraVigilance and FDA FAERS. Deadline tracking that prevents late submissions through automated reminders and escalation rules.
Serialisation platforms that generate unique identifiers for each saleable unit, aggregate at case and pallet level, and produce EPCIS event reports for DSCSA (US) and FMD (EU) compliance. Integration with packaging line equipment including printers, cameras, and rejection systems. Wholesaler and distributor portals for product verification. Suspicious product alert management workflows. Integration with SAP and Oracle ERP systems.
Integration with existing laboratory information management systems to connect analytical results, stability data, and in-process testing records to clinical and regulatory workflows. Custom data pipelines that extract structured results from LIMS and map them to reporting formats. Dashboards that give QA and regulatory teams visibility into laboratory data status without requesting manual reports from lab staff.
AI document tools scoped around specific high-cost manual tasks in pharma. Regulatory document drafting assistance that generates first-draft sections from structured inputs and past submission templates. Clinical data review tools that flag anomalies and protocol deviations in trial datasets. Molecule screening support tools that cross-reference compound data against literature and internal databases. Each tool is designed with output transparency so scientists and regulatory staff know what to verify before relying on the output.
Frequently asked questions
GxP covers the set of Good Practice regulations that apply across pharmaceutical manufacturing, laboratory operations, and clinical research -- GMP, GLP, and GCP. Software used in GxP-regulated processes must meet specific requirements: a complete audit trail of every data entry and change, electronic signature implementation under 21 CFR Part 11, system access controls, and validation documentation (IQ/OQ/PQ). GxP-aware development means designing these controls into the architecture from the start -- not adding them after development is complete. We build the technical requirements. Your qualified validation team performs the formal qualification. We support that process with documentation and test protocols.
Yes. We integrate with Veeva Vault for document management, SAP and Oracle for supply chain and manufacturing data, and most clinical systems that offer an API. For legacy systems without a modern API, we build integration layers using file-based exchange, database connectors, or middleware. The integration approach and complexity depends on what your existing systems support -- we scope this during discovery. EDC and LIMS integrations are among the most common in pharma projects and we have direct experience with both.
21 CFR Part 11 requires electronic signatures to be binding, unique to the individual, and linked to the record they sign. We implement signatures with identity binding -- each signature records the user's identity, the date and time, and the meaning of the signature. Signatures cannot be transferred between users. The system requires re-authentication for signature actions. The full audit trail ties each signature to the specific record version it authorised. We provide architecture documentation for your regulatory team and can support the validation protocol process alongside your qualified person.
A focused first product -- an adverse event reporting system, a regulatory document management platform, or a LIMS integration -- typically runs 12-16 weeks from kickoff to go-live. Clinical trial management platforms are more complex and typically run 4-6 months for a full build. Projects requiring formal validation documentation take longer because the IQ/OQ/PQ process runs alongside and after development. We agree milestones and validation checkpoint dates at the start so your quality team can plan their review schedule.
Tell us which compliance or data process is costing your team the most. We'll tell you how we'd approach it.