Bridging Life Sciences and Intelligent Digital Innovation
We engineer purpose-built digital platforms, automated regulatory engines, and secure data infrastructure for clinical research organizations, laboratories, and health-tech enterprises.
- Domain-Specific Engineering: Built exclusively for life sciences, pharma, and global clinical ecosystems—not adapted from generic IT.
- Built-In Compliance: GxP standards, audit trails, and strict data governance embedded into every layer from day one.
- Workflow Automation: Replacing manual authoring, fragmented lab tracking, and disconnected trial data with structured, scalable systems.
- Global Interoperability: Seamless integration across EDC platforms, LIMS databases, analytics engines, and partner networks.
- Clinical & Regulatory Systems: Accelerated medical authoring, automated compliance reporting, and trial operations.
- Laboratory Data Solutions: Scalable LIMS implementations, data traceability, and high-throughput sample management.
- Connected Health Technology: Robust pipelines connecting disparate clinical, operational, and research databases.
FAQ
GenRAC (Regulatory & Compliance)
What is GenRAC?
GenRAC is GenBioCa’s enterprise regulatory affairs and compliance management engine. It provides automated tracking, gap analysis, and submission lifecycle workflows across global health authorities (including FDA, EMA, PMDA, and CDSCO).
How does GenRAC handle regulatory requirement updates?
It continuously ingests and cross-references regulatory guidances, dynamically flagging discrepancies, submission gaps, and upcoming compliance deadlines across all active dossiers.
Does GenRAC integrate with electronic submission gateways?
Yes. GenRAC supports eCTD publishing standards, validation checkpoints, and electronic submission gateways to ensure dossiers meet agency-specific technical criteria prior to filing.
ClinWrite
What is ClinWrite?
ClinWrite is an AI-powered life sciences authoring and dossier platform covering five specialized pillars: Clinical Writing, Scientific Writing, Medical Communications, Regulatory Writing, and Ideation/Publishing.
Is ClinWrite GxP and 21 CFR Part 11 compliant?
Yes. The platform features role-based access, cryptographic SHA-256 e-signatures, contemporaneous ALCOA+ audit trails, and strict human-in-the-loop validation gates.
Which key clinical and regulatory documents does it support?
It drafts, cross-references, and formats Phase 1–4 Clinical Study Reports (CSRs per ICH E3), Investigator Brochures (IBs), DSURs, PBRERs, CTD Modules 1–5, and peer-reviewed journal manuscripts adhering to ICMJE and CONSORT guidelines.
How does the built-in Medical-Legal-Regulatory (MLR) gate work?
ClinWrite scans slide decks and promotional materials against approved product labels (e.g., SmPC/USPI), flagging unreferenced or unsubstantiated clinical claims to prevent regulatory violations before publication.
GBC-Brix
What is GBC-Brix?
GBC-Brix is an industrial compliance operating system designed for food, beverage, and dairy processors to monitor Critical Control Points (CCPs), track batches farm-to-shelf, and automate multi-framework compliance.
How quickly can Brix trace a product during a recall?
While standard frameworks like FSSC 22000 require recall traceability within 4 hours, Brix executes backward and forward batch tracing in under 2 hours with single-query retrieval.
How does Brix handle live sensor excursions and CCP monitoring?
Brix monitors connected sensors 24/7 (such as pasteurization temperatures, antibiotic residue screening, and cold storage). If a critical threshold breaches, it triggers multi-channel alerts (SMS, push, email) within 60 seconds and auto-generates a CAPA.
What compliance standards are supported?
It tracks and maintains evidence across 14 regulatory frameworks simultaneously, including FSSAI, BIS, FSSC 22000, Legal Metrology, AGMARK, MMPO, ETP, and Energy PAT.
GBC-AMS
What is GBC-AMS?
GBC-Divit is an analytical predictive platform that models the public health and actuarial impacts of climate volatility, extreme weather events, ambient pollution, and thermal stress on population mortality and morbidity.
How does AMS manage equipment maintenance and calibration?
It automates 30-, 15-, and 7-day predictive alerts for sensor calibration, preventive maintenance, and recertification cycles, logging every intervention in an auditable database.
Does AMS support healthcare accreditation audits?
Yes. AMS maintains digital logs of uptime, calibration history, vendor servicing, and validation certificates, enabling one-click generation of equipment evidence packs for inspections (e.g., FDA GxP, ISO 17025, or hospital QA audits).
GBC-Divit
What is GBC-Divit?
GBC-Divit is an analytical predictive platform that models the public health and actuarial impacts of climate volatility, extreme weather events, ambient pollution, and thermal stress on population mortality and morbidity.
Who uses Divit?
Public health organizations, life insurers, reinsurers, and urban healthcare providers use Divit to forecast disease vector outbreaks, calculate environmental health risk scorings, and adjust underwriting and resource allocation.
What data inputs drive Divit's predictive models?
Divit synthesizes longitudinal epidemiological databases, real-time meteorological feeds, satellite air quality metrics (e.g., PM2.5, PM10, AQI), and regional demographic heat maps.
moringa-ai
What is moringa-ai?
Moringa AI is a real-time, climate-intelligent public health and triage platform designed to connect environmental shifts directly to individualized preventive health and clinical emergency triage.
How does moringa-ai connect climate factors with clinical health?
It cross-references hyper-local environmental triggers (heat indices, humidity, localized pollen counts, pollution spikes) with patient biometric and medical risk profiles to recommend preventive interventions and alert clinicians to oncoming acute exacerbations (e.g., respiratory, cardiovascular, and renal conditions).
Can moringa-ai integrate with existing health systems and EHRs?
Yes. Built with standard interoperability protocols (including FHIR/HL7 APIs), Moringa AI interfaces seamlessly with electronic health records, mobile wellness applications, and regional surveillance portals.