Continuous quality & trial integrity for pharmaceutical manufacturers.
BioKinetyc replaces two-week paper QA batch release delays and manual adverse-event coding with domain-specific bio-AI. We inspect HPLC chromatograms and tablet coatings in under 340ms, stratify clinical trial safety cohorts, and automate NAFDAC & WHO-GMP dossiers across 3,400+ active protocols.
AssayVision™ Live QC • 99.4% Confidence
Batch #AF-2094B — HPLC Assay & Dissolution Passed
WHO-GMP COA signed in 14 mins • 21 CFR Part 11 hash locked
The Quality-Release & Trial Lag
Why paper batch records & manual CRFs stall at commercial GMP volume.
Operating pharmaceutical formulation plants and multi-center clinical trials across Nigeria without autonomous analytical telemetry traps hundreds of millions of Naira in quarantined inventory, delays NAFDAC CTD approvals, and risks costly batch recalls.
Legacy Paper QA & CRO Friction
- 0114-Day Batch Quarantine Lags: Finished oral solid and parenteral batches sit in warehouse quarantine for 2+ weeks waiting for manual HPLC chromatogram review and wet-chemistry transcription.
- 02Unflagged Coating & API Impurity Drift: Human visual inspection misses sub-millimeter enteric coating fissures and subtle baseline co-elution peaks, leading to dissolution failures and NAFDAC recalls.
- 03Fragmented Pharmacovigilance & SAE Reporting: Multi-site clinical investigators record adverse events on paper CRFs, delaying MedDRA coding and DSMB safety signal detection by weeks.
- 04NAFDAC / WHO-GMP CTD Dossier Rejections: Disconnected Zone IVb stability logs and transcription typos trigger regulatory queries that stall product registration by 6 to 12 months.
The BioKinetyc Autonomous OS
- ✓AssayVision™ Chromatogram & Optical Triage: Multimodal vision and spectral transformer audits HPLC peaks, FTIR raw API fingerprints, and tablet coatings in < 340ms, cutting batch release to 6 hours.
- ✓VigilanceSentinel™ MedDRA-NLP-v3: Autonomous clinical trial adverse event extraction, CYP450 polypharmacy risk underwriting, and instant ICH-E2B(R3) regulatory reporting.
- ✓TrialEscrow™ Cold-Chain & Milestone Vaults: Multi-currency (USD/NGN) investigator grant disbursements and raw API letters of credit released automatically upon verified COA and temperature telemetry.
- ✓DossierLex™ Automated CTD Compilation: Continuous synchronization of LIMS batch records and Zone IVb stability chambers into audit-ready NAFDAC and WHO-GMP eCTD dossiers.
Raw API to Validated Release
Continuous traceability from incoming assay to NAFDAC dossier.
From inline spectroscopy and optical defect triage to clinical trial pharmacovigilance and escrow settlement, BioKinetyc enforces zero-defect pharmaceutical execution.
01Raw API & Excipient Ingestion
Incoming active pharmaceutical ingredients undergo Raman/FTIR spectral matching and COA verification before TrialEscrow™ releases supplier letter-of-credit tranches.
02AssayVision™ Inline QC Triage
SpectraViT-QC-v4 audits HPLC chromatograms for secondary impurity peaks while high-speed cameras inspect tablet coatings and sterile vials in < 340ms.
03VigilanceSentinel™ Trial Safety
Ingests multi-center clinical investigator notes and patient ePRO telemetry, auto-coding symptoms to MedDRA v27.0 and flagging SAE signals in real time.
04DossierLex™ & 6-Hour Batch Release
Compiles 21 CFR Part 11 electronic signatures, stability profiles, and CAPA logs into NAFDAC/WHO-GMP CTD modules for same-day Qualified Person release.
Test how BioKinetyc accelerates batch release & safety triage live.
Test live HPLC & tablet defect vision triage, MedDRA pharmacovigilance cohort underwriting, and regional batch release optimization across Nigerian pharma corridors.
Select Incoming Analytical / GMP Deviation
- C18 Reverse-Phase Column Purge & Mobile Phase pH Re-buffer: ₦145,000
- USP Reference Standard Re-Injection (Triplicate Assay): ₦165,000
- Qualified Person (QP) 21 CFR Part 11 Deviation Signoff: ₦110,000
Automated LIMS Quarantine + Lead Analytical Chemist Alerted
< 340ms inference • 18-minute column recalibration SLA
21 CFR Part 11 Cloud & Cleanroom Edge
Validated on AWS, NVIDIA & Microsoft Azure.
GxP-validated cloud compute, sub-340ms optical & spectral GPU inference, and hardware-isolated clinical data enclaves engineered for African life sciences.
AWS HealthOmics & KMS
AWS SageMaker GxP model hosting, AWS KMS FIPS 140-2 Level 3 encryption for TrialEscrow™ keys, and Amazon S3 WORM Object Lock for 21 CFR Part 11 batch records.
NVIDIA Clara & TensorRT
NVIDIA TensorRT™ acceleration delivering sub-340ms HPLC chromatogram and high-speed tablet coating inspection on NVIDIA L40S GPUs and cleanroom Jetson appliances.
Microsoft Azure Bio-Enclaves
Azure Confidential Computing (AMD SEV-SNP) for patient clinical trial identity protection and zero-data-retention eCTD regulatory document synthesis.
Audited GMP & CRO Deployments
Adopted by leading pharma manufacturers & trial sites.
Africure Bio-Manufacturing & Formulations Plc
“BioKinetyc’s AssayVision™ connected directly to our Waters Empower HPLC cluster and blister lines in Agbara. We cut batch release turnaround from 14 days to 6 hours and saved ₦320M in prevented quarantine write-offs.”
PanAfrica Clinical Research & Pharmacovigilance CRO Ltd
“Across 18 Phase III infectious disease and oncology trials in Abuja and Ibadan, VigilanceSentinel™ achieved 99.8% MedDRA adverse-event coding concordance while TrialEscrow™ automated investigator grant payouts.”
NileValley Active Ingredients & Parenterals Ltd
“Deploying dark-field AssayVision™ and DossierLex™ across our Enugu and Kano sterile injectable lines delivered zero batch recalls across 1,100 parenteral lots and first-cycle NAFDAC CTD renewals.”
Active Plants & Clinical Trial Sites
GMP production lines & CROs monitored in real time.
From Agbara oral solid dosage facilities to Enugu sterile parenteral suites and Abuja clinical trial networks, BioKinetyc governs 3,400+ active protocols.
Agbara Solid-Dosage CMO Complex
High-speed tableting, blister & HPLC QC cluster
Abuja-Ibadan Multi-Center CRO
Phase II–IV infectious & metabolic clinical network
Enugu Sterile Parenteral Suites
ISO Class 5 lyophilized vials & ampoule filling
Kano Biologics & Cold-Chain Hub
Zone IVb stability & vaccine distribution vault
Scientific & Executive Team
Founded by pharma quality directors & computational biology leads.
Headquartered at 3 Roseline Ezeka Street, Golf Estate, Enugu with GMP validation and clinical engineering desks across Lagos, Abuja, and Kano.
Stephen Nzubechukwu A.
Life-sciences technology executive and institutional systems strategist with deep experience structuring GMP pharmaceutical manufacturing partnerships, multi-site clinical trial escrow architecture, and regulatory compliance workflows across Nigeria and West Africa.
Spearheads BioKinetyc's enterprise deployments across 21 pharmaceutical manufacturers, analytical QC laboratories, and CROs managing 3,400+ batch and clinical protocols.
Adeleke Timothy
Computational biology researcher, computer vision QC architect, and distributed systems engineer with over a decade of experience building spectral anomaly detection pipelines, clinical NLP models, and 21 CFR Part 11 cryptographic audit ledgers.
Leads AI research and GxP cloud engineering at BioKinetyc, architecting our proprietary AssayVision™ (`SpectraViT-QC-v4`) and VigilanceSentinel™ (`MedDRA-NLP-v3`) engines.
Enterprise Plant & CRO Licensing
Modular annual licensing aligned with lab & batch throughput.
Generating ₦1.72M+ MRR across 21 active pharmaceutical plants, QC laboratories, and CROs with immediate working-capital recovery from accelerated batch release.
Ideal for ISO 17025 analytical testing laboratories and boutique formulation plants running up to 150 batch assays monthly.
- Up to 150 batch assays/mo (HPLC, UV-Vis & Dissolution)
- AssayVision™ chromatogram & tablet defect triage
- Automated USP/BP Certificate of Analysis (COA) vault
- 21 CFR Part 11 electronic signature & audit trail
Full autonomous QC, pharmacovigilance, and dossier automation for GMP pharma plants and multi-site CROs.
- Unlimited AssayVision™ inline optical & HPLC QC
- Full VigilanceSentinel™ MedDRA v27.0 pharmacovigilance
- TrialEscrow™ investigator milestone & API LC settlement
- DossierLex™ automated NAFDAC & WHO-GMP CTD compiler
- Waters Empower & Agilent OpenLab native sync
Bespoke multi-plant architecture for large pharmaceutical groups, sterile vaccine facilities, and multinational sponsors.
- Unlimited plants, sterile lines & Phase I–IV trial sites
- Bidirectional SAP QM, Oracle LIMS & Medidata Rave sync
- Dedicated Azure Confidential Enclave & cleanroom edge
- Dedicated Regulatory AI Scientist & 15-minute GxP SLA
GxP Compliance & Validation Q&A
Technical answers for QA directors & regulatory affairs teams.
Everything Qualified Persons (QPs), Directors of Quality Assurance, and Clinical Principal Investigators need to know about validating BioKinetyc.
Need Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation for NAFDAC or WHO-GMP inspectors? Reach out to stephen@biokinetyc.site or 08132262929.
BioKinetyc processes patient clinical trial biomarkers and batch release records inside hardware-isolated Microsoft Azure Confidential Enclaves (AMD SEV-SNP). Every chromatogram spectrum and COA signature is cryptographically hashed on Amazon S3 Object Lock (WORM), meeting FDA 21 CFR Part 11, WHO-GMP Annex 11, and Nigeria Data Protection Act (NDPA 2023) requirements.