Enterprise Pharmaceutical & CRO Infrastructure

How BioKinetyc streamlines QC labs & clinical trials.

BioKinetyc replaces fragmented wet-chemistry binders, manual MedDRA adverse-event coding, and delayed regulatory dossier preparation with a unified, GxP-validated AI stack.

Analytical & Optical QC

AssayVision™ (SpectraViT-QC-v4): Multimodal HPLC & Tablet Defect Triage

Manual wet-chemistry binder verification and visual tablet inspection stall batch releases for up to 14 days while risking human transcription oversight. AssayVision™ ingests raw chromatography channels and high-speed cleanroom optical streams in real time.

HPLC & FTIR Spectral Anomaly Detection: Identifies secondary impurity co-elution, retention time drift, and baseline noise across Waters Empower and Agilent OpenLab feeds in < 340ms.

Inline Solid-Dosage & Parenteral Vision: Detects tablet capping, enteric film-coating micro-fissures, and sub-visible borosilicate vial particulates at 4,200 units/minute.

Automated USP/BP CAPA & COA Generation: Cross-checks assay results against United States and British Pharmacopeia monographs to issue 21 CFR Part 11 signed Certificates of Analysis.

Analytical & Optical QCGxP Validated

Audited Life-Sciences Benchmark

14 Days → 6 Hours Batch Release

₦320M+ saved in prevented batch quarantine write-offs

Deploy Module in Sandbox

Clinical Pharmacovigilance

VigilanceSentinel™ (MedDRA-NLP-v3): Autonomous Adverse Event & Cohort Underwriting

Multi-center clinical trials across West Africa face complex polypharmacy profiles (concomitant antimalarials, ARVs, and botanicals) alongside delayed paper Case Report Form (CRF) coding. VigilanceSentinel™ automates clinical safety surveillance.

Automated MedDRA v27.0 Coding: Extracts symptom narratives from unstructured clinician notes and patient ePRO voice/text logs with 99.8% Lowest Level Term concordance.

CYP450 Polypharmacy Risk Stratification: Scores enrolled patient cohorts (0–850 safety index) for hepatic/renal biomarker drift and drug-drug interaction probability.

Instant ICH-E2B(R3) Regulatory Dispatch: Generates XML safety transmissions ready for NAFDAC National Pharmacovigilance Centre (NPC) and WHO Vigibase.

Clinical PharmacovigilanceGxP Validated

Audited Life-Sciences Benchmark

99.8% MedDRA Coding Concordance

Evaluates cohort safety signals in 2.8 seconds

Deploy Module in Sandbox

Bio-Financial Custody

TrialEscrow™: Multi-Site Investigator Milestone & Cold-Chain API Settlement

Clinical research organizations and pharma plants lose months to disputed investigator site grants, cold-chain excursion write-offs, and cross-border active pharmaceutical ingredient (API) letter-of-credit friction.

Dual-Currency (USD/NGN) Protocol Vaults: Isolates clinical trial site budgets and raw API import letters of credit in CBN-compliant virtual escrow accounts.

IoT Cold-Chain Custody Verification: Locks payout tranches for biologics and vaccines until continuous 2°C–8°C datalogger hashes confirm zero thermal excursion.

Automated eCRF Milestone Disbursement: Releases investigator site grants within 30 minutes of verified patient enrollment and DSMB source-data verification.

TrialEscrow™: Multi-Site Investigator Milestone & Cold-Chain API Settlement

Bio-Financial CustodyGxP Validated

Audited Life-Sciences Benchmark

100% Cold-Chain & Grant Auditability

< 30 minute investigator milestone settlement

Deploy Module in Sandbox

Regulatory Affairs AI

DossierLex™: Automated WHO-GMP / NAFDAC CTD Compilation & Audit Trails

Compiling Common Technical Document (CTD) dossiers for NAFDAC registration, WHO Prequalification, and African Medicines Agency (AMA) harmonisation manually consumes thousands of regulatory affairs hours.

ICH M4 CTD Module 1–5 Auto-Assembly: Pulls validated LIMS batch records, analytical method validations, and bioequivalence summaries into structured eCTD XML.

Climatic Zone IVb Stability Telemetry: Continuously audits 30°C / 75% RH accelerated and long-term stability chamber data against shelf-life specifications.

Immutable 21 CFR Part 11 Audit Vault: Maintains tamper-proof electronic signatures, timestamped change-control logs, and CAPA lineages on AWS S3 Object Lock.

DossierLex™: Automated WHO-GMP / NAFDAC CTD Compilation & Audit Trails

Regulatory Affairs AIGxP Validated

Audited Life-Sciences Benchmark

99.4% First-Cycle Dossier Approval

Full FDA 21 CFR Part 11 & WHO-GMP Annex 11 compliance

Deploy Module in Sandbox

Ready to modernize your GMP plant or clinical CRO?

Join 21 pharmaceutical manufacturers, analytical QC laboratories, and CROs automating 3,400+ batch and clinical protocols on BioKinetyc.

Deploy 30-Day GxP Sandbox Schedule QP & Regulatory Briefing