Custom software for biotech companies, CROs, and research organisations whose laboratory workflows, data volumes, and regulatory obligations require more than generic LIMS platforms or spreadsheet-based tracking can deliver.
Built with regulatory compliance designed in from the start -- audit trails, electronic signatures, data integrity controls, and the validation documentation FDA and EMA inspectors expect -- not retrofitted after the platform is built.
LIMS with sample lifecycle management, instrument integration, and audit-ready data capture
Electronic lab notebooks replacing paper records with structured, searchable, 21 CFR Part 11 compliant data
Clinical trial data management -- protocol tracking, subject management, AE reporting, and regulatory submissions
Bioinformatics pipelines for genomics, proteomics, and next-generation sequencing data processing
Summary
RaftLabs builds custom biotech and life sciences software -- laboratory information management systems (LIMS), clinical trial data management, bioinformatics pipelines, electronic lab notebooks, FDA 21 CFR Part 11 compliant systems, sample tracking, genomics data platforms, and regulatory submission tools. Most biotech software projects deliver in 14 to 20 weeks at a fixed, agreed cost with full source code ownership.
100+Products shipped
·24+Industries served
·FixedCost delivery
·14-20Week delivery cycles
Regulatory compliance is not a feature you add later in life sciences software
Biotech and life sciences software operates under regulatory frameworks -- FDA 21 CFR Part 11, EU Annex 11, GxP guidelines -- that require audit trails, electronic signatures, access controls, and data integrity protections to be built into the system architecture from the start. Platforms built without these controls and later validated for regulatory use are expensive to retrofit and create ongoing validation burden every time a change is made.
We build life sciences software with the compliance architecture in place from the first sprint. The audit trail captures every data creation, modification, and deletion event with user identity and timestamp. Electronic signatures meet the definition under 21 CFR Part 11. Access controls are role-based and documented. The validation approach -- IQ, OQ, PQ documentation -- is scoped at the start of the project so the system is inspection-ready when it goes live.
What we build
Laboratory Information Management System (LIMS)
Sample registration and tracking through every stage of the laboratory workflow -- receipt, storage, testing, review, and disposal -- with sample status and location visible at all times. Test order management linking samples to the analytical methods and instrument assignments for each test. Result capture from instrument integrations (direct API or file-based import) and manual entry with the units, ranges, and pass/fail criteria for each test type. Result review and approval workflow with electronic signature. Certificate of analysis generation from approved results. The LIMS that replaces paper worksheets and gives your laboratory the data traceability a regulatory inspection requires.
Electronic lab notebook (ELN)
Structured experiment records replacing paper lab notebooks with searchable, version-controlled, electronically signed entries. Experiment templates capturing the protocol, materials, equipment, and observations in a consistent format. Data attachment supporting instrument exports, images, chromatograms, and spectra linked to the experiment record. Collaboration features for multi-researcher experiments with contribution tracking. IP protection through timestamped, countersigned records that establish priority and demonstrate inventive step. The ELN that makes research data findable, shareable, and defensible.
Clinical trial data management
Protocol management capturing the study design, endpoints, visit schedule, and inclusion/exclusion criteria. Subject enrolment and randomisation with eligibility verification against the protocol criteria. Electronic data capture (EDC) for case report form completion with field-level validation and query management. Adverse event and SAE reporting with regulatory notification workflow. Site management covering investigator site files, monitoring visit records, and deviation tracking. Clinical data export in CDISC SDTM and ADaM format for regulatory submission. The clinical data platform that keeps your study in protocol and your submission data structured for FDA review.
Bioinformatics pipeline platform
Next-generation sequencing data processing pipelines covering alignment, variant calling, annotation, and quality control with configurable workflow steps and parameter management. Genomics data storage with sample linkage, metadata management, and version control for reference data. Pipeline execution management showing run status, resource usage, and output file tracking. Results visualisation for variant data, expression profiles, and pathway analysis. Data sharing with controlled access for collaboration between internal and external research teams. The bioinformatics infrastructure that turns raw sequencing output into analysed, reproducible, shareable results.
FDA 21 CFR Part 11 compliance
Audit trail capturing every record creation, modification, and deletion with the user identity, timestamp, and previous value -- the complete change history that 21 CFR Part 11 and EU Annex 11 require. Electronic signature workflow with identity verification, meaning capture, and the binding of the signature to the record. Access control with role-based permissions, password policy enforcement, and inactivity timeout. System validation documentation -- User Requirements Specification, Functional Specification, IQ/OQ/PQ protocols, and Validation Summary Report -- produced alongside the software. Change control procedure for post-validation modifications maintaining the validated state. The compliance architecture that makes the system inspection-ready rather than inspection-vulnerable.
Regulatory data and submission tools
Data compilation tools aggregating study data, analytical results, and supporting documentation into the structured format required for IND, NDA, BLA, or MAA submissions. eCTD document management with module structure, document versioning, and submission package assembly. Regulatory correspondence tracking with response timelines and commitment management. Post-approval change control documentation workflow. The regulatory data management that reduces the time between study completion and submission ready by making the submission data a structured output of normal operations rather than a manual compilation exercise.
Frequently asked questions
Validation is scoped as part of the development project rather than treated as a separate post-development activity. We produce the User Requirements Specification and Functional Specification during the discovery phase so requirements are documented before development starts. Installation Qualification and Operational Qualification protocols are written in parallel with development and executed during the testing phase. Performance Qualification is executed with the client's validation team against their specific processes. The Validation Summary Report and supporting documentation are delivered alongside the software. The validation approach is discussed and agreed at project kickoff so the timeline and deliverables are clear.
Yes. Instrument integration is a core part of LIMS implementation. We support direct API integration where instruments provide it, bi-directional instrument interfaces via ASTM or HL7 protocols, file-based import from instrument software exports (CSV, XML, proprietary formats), and middleware integration platforms. The integration approach for each instrument is assessed during discovery -- not all instruments provide equivalent integration capability, and we confirm what is achievable for your specific equipment before development starts.
Genomics data is large by nature and the storage and compute architecture needs to be designed for it from the start. We build bioinformatics platforms on cloud infrastructure (AWS, Azure, or GCP) with scalable storage and on-demand compute for pipeline execution, so you pay for the capacity you use rather than provisioning for peak. Data archiving workflows manage the lifecycle of raw sequencing files, intermediate files, and final outputs. We assess your anticipated data volume and pipeline complexity during discovery and propose the right infrastructure architecture before development starts.
A LIMS covering sample tracking, test management, result capture, and audit trail typically runs $55,000 to $110,000. A more complete platform with ELN, clinical data management, or bioinformatics pipeline integration typically runs $110,000 to $220,000. Validation documentation is included in the project scope and cost. Fixed cost agreed before development starts.
Biotech software by product
LIMS Development -- sample tracking, instrument integration, result management, and CoA generation
AI Development -- ML models for genomics, drug discovery, and clinical prediction
Talk to us about your biotech software project.
Tell us your laboratory workflows, your regulatory obligations, and where your current systems create compliance risk or research inefficiency. We'll scope the right platform and give you a fixed cost.
