Independent toxicological evaluation
Signed assessments of ingredient and finished-product safety. Hazard characterization, dose–response review, and uncertainty analysis structured for regulator and retailer scrutiny.
Independent scientific consulting · Exposure-based risk assessment
Scientific safety and regulatory governance for regulated industries.
The Agyekum Group (AG) provides independent scientific consulting across cosmetics, personal care, consumer products, medical devices, pharmaceuticals, industrial chemicals, and environmental health. We deliver exposure-based risk assessment, toxicological evaluation, regulatory strategy, safety substantiation, and scientific governance to support product development, market access, regulatory compliance, and litigation.
The same exposure-based scientific methodology underpins every engagement, regardless of industry, product category, or regulatory framework. Our approach integrates toxicology, exposure science, risk assessment, and regulatory strategy to deliver scientifically defensible decisions across regulated industries.
Platform access available below.
Platform · supports the consulting practice
Toxicology Intelligence
ToxIntel is Aᴳ’s enterprise scientific safety intelligence platform — a distinct product built to operationalize toxicological assessment, regulatory workflows, scientific governance, and product stewardship. It supports, but does not replace, the consulting practice.
Practice capabilities
Where Aᴳ is engaged.
Five practice areas anchor every engagement. Each is signed by a named toxicologist and documented for the next reader — regulator, retailer, or court.
Exposure-based risk assessment
Quantitative SED / NOAEL / MoS / BMD analyses per population band. Pathway-specific exposure modelling for dermal, oral, inhalation, and mucosal use.
Cosmetic & consumer product safety
Product-level safety substantiation across cosmetics, personal care, fragrance, ingestibles, and adjacent consumer categories — fit for MoCRA, EU 1223, and IFRA contexts.
Regulatory & litigation support
Toxicology-led regulatory strategy and litigation-aware documentation. Independent expert review, Prop 65 exposure framing, and enforcement-relevant scientific narrative.
Toxicology intelligence via ToxIntel
Aᴳ’s in-house platform — contaminant surveillance, formulation review, compliance passport export, and continuously updated regulatory context. Made available to enterprise clients.
Continuous regulatory monitoring
Federal Register, FDA, CPSC, OEHHA, and FTC signals tracked and interpreted — surfaced below in Toxicology Watch and integrated into client briefings.
Frameworks & methodology
The science we apply.
Every Aᴳ evaluation references the same regulatory frameworks and scientific methodologies a competent authority, retailer, or court would reference. We are explicit about which framework applies, where its boundary lies, and what evidence the engagement produces.
Regulatory frameworks
Modernization of Cosmetics Regulation Act
MoCRA
U.S. cosmetic facility & product registration, adverse-event reporting, safety-substantiation evidence requirements.
Regulation (EC) No 1223/2009
EU Cosmetics Regulation 1223/2009
Cosmetic Product Safety Reports (CPSR), responsible-person obligations, Annex II/III/IV/V/VI ingredient controls.
Safe Drinking Water and Toxic Enforcement Act
California Proposition 65
Exposure-based assessment vs Safe Harbor Levels; warning-decision logic; NSRL / MADL framing.
Regulation (EC) No 1907/2006
REACH
EU registration, evaluation, authorisation, and restriction of chemicals — hazard, exposure, and risk characterisation for substances placed on the EU market.
Regulation (EC) No 1272/2008
CLP
Classification, labelling, and packaging of substances and mixtures — hazard-class assignment, pictogram selection, and label composition per EU CLP.
OSHA HCS · UN GHS Purple Book
OSHA Hazard Communication · GHS
Hazard-communication classification, SDS authoring, and global-market label harmonisation via the Globally Harmonized System.
Biological evaluation of medical devices
ISO 10993
Toxicological risk assessment, biological evaluation planning, and chemical-characterisation review — scientific support only, not certification.
Mutagenic impurities in pharmaceuticals
ICH M7
Nitrosamine and DNA-reactive impurity assessment, TTC-based control strategies, and PDE-derivation support for drug substances and products.
EU Scientific Committee on Consumer Safety
SCCS Opinions
Authoritative EU opinions on cosmetic ingredients; SCCS Notes of Guidance methodology baseline.
International Fragrance Association
IFRA Standards
Fragrance-ingredient use restrictions, dermal sensitization QRA, category-specific limits.
Scientific frameworks
SED · MoS · BMD methodology
Exposure-based risk assessment
Quantitative dermal, oral, inhalation, and mucosal exposure modelling per population band.
NOAEL / LOAEL → MoS
Margin of Safety
Internal-dose modelling against point-of-departure values; uncertainty factor selection and justification.
Hazard characterization
Ingredient hazard review
Acute, subchronic, and chronic endpoint review across genotoxicity, sensitization, irritation, repro/dev, and systemic toxicity.
WoE evaluation
Weight-of-evidence review
Structured integration of human, animal, in-vitro, and in-silico data streams with study-quality weighting.
Claim & label substantiation
Scientific substantiation
Defensible documentation of safety, performance, and regulatory claims for retailer and litigation contexts.
All assessments are signed by a named toxicologist · documented for regulatory, retailer, and litigation contexts.
01 — Scope
Where the work is documented to support third-party scrutiny.
Regulatory & Governance
Toxicology and risk assessment aligned with EU, FDA, and international frameworks where safety substantiation and exposure analysis are required.
Retail Compliance
Evaluation of formulations and ingredients against exposure-based safety criteria and documentation standards applied in retailer governance.
Legal & Enforcement
Independent toxicological analysis of chemical exposure, dose–response, causation, and complex data — structured to withstand legal scrutiny.
Ingredient & Raw Material
Hazard characterization, exposure considerations, and regulatory status review of ingredients in support of downstream use.
02 — Scientific practice
Eight scientific practice areas. One consistent standard of evidence.
Aᴳ delivers scientific consulting across cosmetics, personal care, consumer products, pharmaceuticals, medical devices, industrial chemicals, and environmental toxicology. The same exposure-based methodology, board-certified oversight, and documentation discipline scales across every practice we engage.
ToxIntel is our enterprise scientific safety intelligence platform — a distinct product that operationalizes many of these workflows. It supports, but does not replace, the consulting practice.
01 · Practice
AvailableProduct Safety & Toxicological Assessment
Foundational scientific assessment across every regulated category we serve.
Independent toxicological evaluation, exposure-based risk assessment, and defensible safety opinions — the scientific core of every Aᴳ engagement, regardless of product class. The practice explicitly supports multi-pathway and aggregate exposure evaluation across dermal, inhalation, oral, and incidental-ingestion routes; pathway aggregation is performed only when scientifically appropriate — not by summing unrelated estimates.
- Ingredient Safety Assessments
- Formula Safety Assessments
- Toxicological Risk Assessment (TRA)
- Quantitative Risk Assessment (QRA)
- Exposure Assessment · dermal / inhalation / oral / incidental
- Multi-Pathway & Aggregate Exposure Assessment
- Route-Specific → Systemic → Aggregate → Risk Characterization
- Margin of Safety (MoS) · MOE · HQ / HI · cancer & non-cancer risk
- Population-specific & acute/chronic exposure scenarios
- Scientific Safety Opinions
- Board-Certified Toxicologist Review
- Product Stewardship Support
- Uncertainty characterization & documentation
Industries
CosmeticsPersonal CareConsumer ProductsHome Fragrance & Air CarePharmaceuticalsMedical DevicesIndustrial Chemicals
Applicable regulations
FDA MoCRAEU 1223/2009REACHIFRAProp 65TSCAUS EPA guidance
Related ToxIntel capability
Exposure, MoS & Aggregate-Exposure workflows
02 · Practice
AvailableCosmetics & Personal Care
Scientific foundation of the practice
The scientific foundation the practice scales from.
Full-stack cosmetic and personal-care safety governance — from ingredient-level toxicology through Cosmetic Product Safety Reports, MoCRA readiness, and retailer compliance dossiers.
- Cosmetic Product Safety Reports (CPSR)
- MoCRA Consulting
- EU Cosmetic Compliance
- IFRA Safety Assessment
- Product Information Files (PIF)
- Claims Support
- Pregnancy & Breastfeeding Safety Reviews
- Pediatric Safety Reviews
- Retail Compliance
- Ingredient Intelligence
Industries
Skin CareHair CareFragranceColor CosmeticsProfessional BeautyMen’s Grooming
Applicable regulations
FDA MoCRAEU 1223/2009SCCS Notes of GuidanceIFRAProp 65
Related ToxIntel capability
CPSR & MoCRA dossier automation
03 · Practice
AvailableConsumer Products
Exposure-based safety governance beyond beauty.
Toxicological assessment for household, cleaning, air-care, pet, children’s, lifestyle, and wellness products — grounded in the same exposure-based methodology that powers our cosmetic practice. Home-fragrance and air-care programs are served through the dedicated Home Fragrance & Air Care vertical.
- Household Cleaning Products
- Air Care
- Laundry Products
- Surface Cleaners
- Pet Products
- Children’s Products
- Lifestyle Products
- Wellness Products
Industries
Household ProductsCleaning ProductsAir CarePet ProductsChildren’s Products
Applicable regulations
CPSCFIFRAProp 65OSHA HazComREACH
Related ToxIntel capability
Multi-category exposure modelling
04 · Practice
Expert-led consultingPharmaceuticals
Expert-led pharmaceutical toxicology and impurity science.
Consulting on pharmaceutical impurity risk, occupational exposure limits, nitrosamine assessment, and toxicological support for drug development. Expert-led — not automated software capabilities.
- PDE Derivation
- Occupational Exposure Limit (OEL) Support
- ICH M7 Scientific Review
- Nitrosamine Risk Assessment
- Impurity Qualification
- Pharmaceutical Toxicology
- Extractables & Leachables Review
- Occupational Toxicology
Industries
Drug ProductsDrug SubstancesManufacturingPharmaceutical Development
Applicable regulations
ICH M7ICH Q3A/B/C/DEMA PDE GuidelineUSP <232>/<233>OSHA
Related ToxIntel capability
ICH M7 & PDE workflow templates
05 · Practice
Expert-led consultingMedical Devices
Toxicological evaluation and biological-evaluation scientific support.
Expert-led toxicological evaluation, biological evaluation planning, and material risk assessment supporting medical-device programs. Scientific consulting only — we do not provide certification, notified-body services, or regulatory decisions.
- ISO 10993 Toxicological Risk Assessment
- Biological Evaluation Planning
- Chemical Characterization Review
- Material Risk Assessment
- Extractables & Leachables
- Patient Exposure Assessment
- FDA Scientific Support
- MDR Scientific Support
- Device Material Safety Review
Aᴳ provides toxicological evaluations, biological-evaluation scientific support, and risk assessment for medical-device programs. Aᴳ does not provide FDA approval, EU MDR approval, certification, notified-body services, or regulatory-authority decisions.
Industries
Patient Contact DevicesCombination ProductsMedical PackagingImplantable DevicesDisposable Devices
Applicable regulations
ISO 10993 seriesFDA guidance (scientific support)EU MDR (scientific support)ISO 14971USP <661.1>/<661.2>
Related ToxIntel capability
ISO 10993 TRA & E&L workflow templates
06 · Practice
AvailableRegulatory Science
Cross-jurisdiction regulatory strategy grounded in defensible science.
Regulatory scientific consulting across chemistry, exposure, and hazard-communication frameworks — from California Prop 65 through REACH, CLP, and global GHS.
- Proposition 65
- REACH
- CLP
- OSHA Hazard Communication
- GHS Classification
- SDS Authoring
- Global Regulatory Strategy
- Scientific Regulatory Support
Industries
CosmeticsConsumer ProductsIndustrial ChemicalsPharmaceuticals
Applicable regulations
Prop 65REACH (EC) 1907/2006CLP (EC) 1272/2008OSHA HCSUN GHS
Related ToxIntel capability
Prop 65 & GHS classification workflows
07 · Practice
Expert-led consultingEcotoxicology & Environmental Fate
Ecological receptors, environmental fate, persistence, and bioaccumulation.
Scientific consulting focused on non-human environmental receptors: aquatic and terrestrial ecotoxicology, environmental fate and transport, persistence, bioaccumulation, and PBT / vPvB / PMT screening. Human-health risk assessment is served through the dedicated EPA Human Health & Environmental Risk Assessment practice.
- Aquatic & terrestrial ecotoxicology
- Environmental fate & transport
- Persistence & degradation assessment
- Bioaccumulation assessment
- PBT · vPvB · PMT screening
- Environmental hazard characterization
- Aquatic toxicity evaluation
- PEC / PNEC & environmental risk characterization
- Environmental exposure & fate data review
- Environmental data-gap assessment
Industries
Sustainability ProgramsChemical StewardshipEnvironmental RiskIndustrial Chemicals
Applicable regulations
REACH Annex XIIIECHA GuidanceOECD Test GuidelinesStockholm Convention
Related ToxIntel capability
PBT / vPvB / PMT screening workflow
08 · Practice
Expert-led consultingScientific Intelligence
Independent scientific review, evidence synthesis, and expert-witness support.
Literature reviews, weight-of-evidence assessments, scientific due diligence, and independent scientific review — for M&A diligence, litigation, and governance programs that require defensible scientific opinion.
- Literature Reviews
- Scientific Evidence Review
- Weight-of-Evidence Assessments
- Systematic Literature Review
- Scientific Due Diligence
- Expert Witness Support
- Scientific Governance
- Independent Scientific Review
Industries
Legal & EnforcementM&A DiligenceInsurance & ReinsuranceRetail Governance
Applicable regulations
Framework-agnostic — evidence synthesis across all applicable jurisdictions
Related ToxIntel capability
Evidence-synthesis & WoE workspace
09 · Practice
AvailableHome Fragrance & Air Care
Toxicology, exposure, and regulatory support across candles, diffusers, sprays, plug-ins, wax melts, and incense.
A dedicated scientific practice for the home-fragrance and air-care category — candles, scented candles, reed diffusers, room sprays, plug-in devices, wax melts, incense, and adjacent products. Inhalation-first exposure characterization combined with dermal and incidental-oral pathways where appropriate, aligned to IFRA use categories, GHS/CLP hazard classification, Prop 65, and EU/GB PCN·UFI readiness. Aᴳ does not issue IFRA certification and does not act as a third-party certification body — services are independent scientific consulting and documentation review.
- Toxicological safety assessment
- Ingredient & formulation review
- Fragrance safety assessment
- Inhalation exposure assessment
- Multi-pathway exposure assessment
- IFRA compliance review
- GHS / CLP classification
- SDS preparation & review
- California Proposition 65 assessment
- EU / GB regulatory support
- UFI / PCN readiness
- ASTM-related candle safety support
- Environmental hazard assessment
- Claims review
- Product stewardship
Aᴳ provides independent toxicological evaluation, exposure characterization, and regulatory scientific consulting for home-fragrance and air-care products. Aᴳ does not perform IFRA certification, does not act as a notified body, and does not issue third-party regulatory approvals.
Industries
CandlesScented CandlesReed DiffusersRoom SpraysPlug-insWax MeltsIncenseConsumer Products
Applicable regulations
IFRA StandardsEU CLPEU CLP CLP-PCN (UFI)GB CLPProp 65ASTM F2417 / F2179 (candle safety)
Related ToxIntel capability
Inhalation & Aggregate Exposure workflows
10 · Practice
Expert-led consultingEPA Human Health & Environmental Risk Assessment
EPA-aligned human-health risk assessment: hazard identification through risk characterization.
Independent human-health risk-assessment consulting using EPA-aligned scientific methodology — hazard identification, dose-response, exposure assessment, and risk characterization for site-, chemical-, occupational-, and product-related HHRA. Multi-pathway and aggregate exposure across dermal, inhalation, and oral routes; drinking-water, soil, dietary, and air pathways where applicable. Scientific interpretation of authoritative EPA toxicology information (IRIS, PPRTV, Regional Screening Levels, Exposure Factors Handbook). Aᴳ is not EPA and does not act on EPA’s behalf.
- Human-health risk assessment (site · chemical · occupational · product)
- Hazard identification
- Dose-response assessment
- RfD / RfC / POD / BMDL derivation & review
- Exposure assessment (dermal · inhalation · oral)
- Multi-pathway & aggregate exposure
- Drinking-water · soil · dietary · air pathways
- Acute & chronic exposure scenarios
- Sensitive populations & lifestages
- HQ · HI · MOE
- LADD & cancer-risk characterization
- Uncertainty analysis
- Application of IRIS / PPRTV / RSL / EPA Exposure Factors Handbook values
- TSCA-related toxicology support
- Weight-of-evidence evaluation
- Read-across & data-gap assessment
Aᴳ provides independent scientific consulting using EPA-aligned human-health risk-assessment methods and interprets authoritative EPA toxicology information (IRIS, PPRTV, RSL, Exposure Factors Handbook). Aᴳ is not EPA, does not act on EPA’s behalf, does not issue EPA regulatory decisions, and does not operate live EPA database integrations on this website.
Industries
Industrial ChemicalsConsumer ProductsEnvironmentalSustainability ProgramsChemical Stewardship
Applicable regulations
EPA-aligned scientific methodologyTSCAFIFRACERCLAIRIS · PPRTV · RSL · Exposure Factors (interpretation)
Related ToxIntel capability
HHRA & Aggregate-Exposure workflows
03 — Industries we serve
Regulated categories, one scientific standard.
Aᴳ engages across the regulated categories where exposure-based safety assessment, defensible documentation, and independent scientific opinion carry commercial and regulatory consequence. The same scientific methodology scales across every category we serve.
Cosmetics & Personal Care
- Skin Care
- Hair Care
- Fragrance
- Color Cosmetics
- Professional Beauty
- Men’s Grooming
Consumer Products
- Household Products
- Cleaning Products
- Air Care · see Home Fragrance & Air Care
- Pet Products
- Children’s Products
Home Fragrance & Air Care
- Candles & Scented Candles
- Reed Diffusers
- Room Sprays
- Plug-in Devices
- Wax Melts
- Incense
- Adjacent home-fragrance products
Pharmaceuticals
- Drug Products
- Drug Substances
- Manufacturing
- Pharmaceutical Development
Medical Devices
- Patient Contact Devices
- Combination Products
- Medical Packaging
- Implantable Devices
- Disposable Devices
Industrial Chemicals
- Specialty Chemicals
- Raw Materials
- Chemical Manufacturers
Environmental
- Sustainability Programs
- Chemical Stewardship
- Environmental Risk
04 — Scientific utilities
Practical scientific tools, mapped to consulting and platform capability.
A public catalog of the scientific utilities the practice engages, organised by scientific domain. Each utility declares its status, its ToxIntel Enterprise module (where available), and the consulting service that supports it.
Items marked Available in ToxIntel Enterprise operate as fully-supported workflows inside the platform. Items marked Available through Scientific Consulting are delivered as expert-led engagements. Nothing in this catalog is exposed as an automated public calculator on this website.
Cosmetics & Personal Care
Margin of Safety Calculator
AvailableNOAEL → SED → MoS with population-band uncertainty factors and Aᴳ documentation trail.
- Service
- Cosmetics & Personal Care
- Industry
- Skin Care · Hair Care
- ToxIntel module
- MoS Workflow
- Utility ID
- CPC-MOS-01
Available in ToxIntel Enterprise
Systemic Exposure Dose Calculator
AvailableSED estimation from product concentration, dermal/oral/inhalation retention factors, and use frequency.
- Service
- Cosmetics & Personal Care
- Industry
- Cosmetics · Personal Care
- ToxIntel module
- Exposure Workflow
- Utility ID
- CPC-SED-01
Available in ToxIntel Enterprise
Dermal Exposure Calculator
AvailableLeave-on / rinse-off / mucosal pathway modelling with SCCS retention defaults.
- Service
- Cosmetics & Personal Care
- Industry
- Skin Care · Color Cosmetics
- ToxIntel module
- Exposure Workflow
- Utility ID
- CPC-DER-01
Available in ToxIntel Enterprise
IFRA Category Selector
Expert review requiredMap fragrance ingredients to IFRA use categories; identify applicable QRA limits.
- Service
- Cosmetics & Personal Care
- Industry
- Fragrance
- ToxIntel module
- IFRA Workflow (planned)
- Utility ID
- CPC-IFRA-01
Available through Scientific Consulting
Cosmetic Ingredient Screening
AvailableScreen ingredient lists against restricted / monitored substances and Prop 65 markers.
- Service
- Cosmetics & Personal Care
- Industry
- Cosmetics · Personal Care
- ToxIntel module
- Hazard Intelligence
- Utility ID
- CPC-SCR-01
Available in ToxIntel Enterprise
Ingredient Concentration Converter
Planned% w/w ↔ ppm ↔ mg/g conversions with formula-basis and dilution rounding.
- Service
- Cosmetics & Personal Care
- Industry
- Cosmetics · Consumer Products
- ToxIntel module
- Utility (planned)
- Utility ID
- CPC-CNV-01
Available through Scientific Consulting
Exposure Scenario Builder
AvailableStructured scenario capture: population, frequency, product form, retention, and pathway.
- Service
- Cosmetics & Personal Care
- Industry
- Cosmetics · Personal Care
- ToxIntel module
- Exposure Workflow
- Utility ID
- CPC-ESB-01
Available in ToxIntel Enterprise
Toxicological Risk Assessment
TRA Workflow
AvailableStructured toxicological risk assessment from hazard identification through characterization. Live via the Aᴳ /upload → assessment pipeline.
- Service
- Product Safety & Toxicological Assessment
- Industry
- Multi-industry
- ToxIntel module
- TRA Workflow
- Utility ID
- TRA-WF-01
Available in ToxIntel Enterprise
QRA Workflow
AvailableQuantitative risk assessment with SED, Margin of Safety, and uncertainty documentation. Live via the Aᴳ full-QRA assessment pipeline.
- Service
- Product Safety & Toxicological Assessment
- Industry
- Multi-industry
- ToxIntel module
- QRA Workflow
- Utility ID
- TRA-QRA-01
Available in ToxIntel Enterprise
Aggregate Exposure Estimator
BetaCombined exposure across multiple products / pathways for the same substance.
- Service
- Product Safety & Toxicological Assessment
- Industry
- Cosmetics · Consumer Products
- ToxIntel module
- Aggregate Exposure (planned)
- Utility ID
- TRA-AGG-01
In beta inside ToxIntel Enterprise
NOAEL Reference Utility
AvailablePoint-of-departure extraction and reference-value lookup with study-quality tagging.
- Service
- Product Safety & Toxicological Assessment
- Industry
- Multi-industry
- ToxIntel module
- NOAEL Extraction
- Utility ID
- TRA-NOAEL-01
Available in ToxIntel Enterprise
Point-of-Departure Comparison
BetaSide-by-side NOAEL / LOAEL / BMD / TTC candidates with justification capture.
- Service
- Product Safety & Toxicological Assessment
- Industry
- Multi-industry
- ToxIntel module
- PoD Comparison
- Utility ID
- TRA-POD-01
In beta inside ToxIntel Enterprise
Uncertainty Factor Reference
Expert review requiredInterspecies / intraspecies / route / duration UF reference with justification prompts.
- Service
- Product Safety & Toxicological Assessment
- Industry
- Multi-industry
- ToxIntel module
- UF Reference (planned)
- Utility ID
- TRA-UF-01
Available through Scientific Consulting
Weight-of-Evidence Worksheet
Expert review requiredStructured WoE integration across human, animal, in-vitro, and in-silico data streams.
- Service
- Scientific Intelligence
- Industry
- Legal · M&A · Governance
- ToxIntel module
- WoE Workspace (planned)
- Utility ID
- TRA-WOE-01
Available through Scientific Consulting
Pharmaceuticals
PDE Estimator
Expert review requiredPermitted Daily Exposure derivation per EMA / ICH Q3D methodology.
- Service
- Pharmaceuticals
- Industry
- Drug Products · Manufacturing
- ToxIntel module
- PDE Workflow (planned)
- Utility ID
- PHR-PDE-01
Available through Scientific Consulting
Occupational Exposure Assessment
Expert review requiredOEL derivation and category-band screening for pharmaceutical manufacturing.
- Service
- Pharmaceuticals
- Industry
- Manufacturing
- ToxIntel module
- OEL Workflow (planned)
- Utility ID
- PHR-OEL-01
Available through Scientific Consulting
Nitrosamine Assessment Workspace
Expert review requiredStructured nitrosamine impurity risk assessment aligned to EMA / FDA guidance.
- Service
- Pharmaceuticals
- Industry
- Drug Products · Drug Substances
- ToxIntel module
- Nitrosamine Workspace (planned)
- Utility ID
- PHR-NIT-01
Available through Scientific Consulting
ICH M7 Decision Support
Expert review requiredDNA-reactive impurity classification, TTC / staged-limits, and control-strategy reasoning.
- Service
- Pharmaceuticals
- Industry
- Drug Products · Drug Substances
- ToxIntel module
- ICH M7 Workflow (planned)
- Utility ID
- PHR-ICHM7-01
Available through Scientific Consulting
Impurity Qualification Workspace
Expert review requiredStructured qualification of API impurities across ICH Q3A/B/C with justification.
- Service
- Pharmaceuticals
- Industry
- Drug Substances · Manufacturing
- ToxIntel module
- Impurity Workspace (planned)
- Utility ID
- PHR-IMP-01
Available through Scientific Consulting
Medical Devices
ISO 10993 Biological Evaluation Planner
PlannedEndpoint selection and evaluation-plan scaffolding per ISO 10993-1 categories.
- Service
- Medical Devices
- Industry
- Patient Contact · Combination Products
- ToxIntel module
- ISO 10993 Planner (planned)
- Utility ID
- MDV-BEP-01
Available through Scientific Consulting
Material Characterization Checklist
PlannedStructured chemical characterization inventory: composition, extractables coverage, testing rationale.
- Service
- Medical Devices
- Industry
- Medical Packaging · Implantable
- ToxIntel module
- Material Characterization (planned)
- Utility ID
- MDV-MAT-01
Available through Scientific Consulting
Extractables & Leachables Planning Worksheet
PlannedE&L study-design planning across analytical thresholds, solvent selection, and reporting.
- Service
- Medical Devices
- Industry
- Implantable · Combination Products
- ToxIntel module
- E&L Workspace (planned)
- Utility ID
- MDV-EL-01
Available through Scientific Consulting
Patient Contact Classification Helper
PlannedCategory / type / duration classification decision-support per ISO 10993-1.
- Service
- Medical Devices
- Industry
- Patient Contact Devices
- ToxIntel module
- ISO 10993 Planner (planned)
- Utility ID
- MDV-CLS-01
Available through Scientific Consulting
Device Risk Planning Tool
PlannedToxicological risk planning aligned to ISO 14971 and biological-evaluation deliverables.
- Service
- Medical Devices
- Industry
- Patient Contact · Disposable
- ToxIntel module
- Risk Planning (planned)
- Utility ID
- MDV-RSK-01
Available through Scientific Consulting
Environmental Toxicology
PBT Screening
PlannedPersistence, bioaccumulation, toxicity screen per REACH Annex XIII criteria.
- Service
- Environmental Toxicology
- Industry
- Sustainability · Chemical Stewardship
- ToxIntel module
- PBT Screening (planned)
- Utility ID
- ENV-PBT-01
Available through Scientific Consulting
vPvB Screening
PlannedVery persistent / very bioaccumulative screen aligned to ECHA guidance.
- Service
- Environmental Toxicology
- Industry
- Chemical Stewardship
- ToxIntel module
- vPvB Screening (planned)
- Utility ID
- ENV-VPVB-01
Available through Scientific Consulting
PMT Screening
PlannedPersistent / mobile / toxic screen for water-mobile contaminants.
- Service
- Environmental Toxicology
- Industry
- Environmental Risk
- ToxIntel module
- PMT Screening (planned)
- Utility ID
- ENV-PMT-01
Available through Scientific Consulting
Environmental Exposure Planner
PlannedStructured environmental exposure scenario capture (fate, release, receptor).
- Service
- Environmental Toxicology
- Industry
- Environmental Risk
- ToxIntel module
- Env Exposure (planned)
- Utility ID
- ENV-EXP-01
Available through Scientific Consulting
Environmental Risk Worksheet
PlannedPEC / PNEC comparison and RCR workflow for aquatic and terrestrial endpoints.
- Service
- Environmental Toxicology
- Industry
- Sustainability · Environmental Risk
- ToxIntel module
- Env Risk (planned)
- Utility ID
- ENV-RSK-01
Available through Scientific Consulting
Regulatory Science
Proposition 65 Screening
AvailableExposure-based Prop 65 screening: pathway estimates vs NSRL / MADL Safe Harbor Levels.
- Service
- Regulatory Science
- Industry
- Cosmetics · Consumer Products · Industrial
- ToxIntel module
- Prop 65 Workflow
- Utility ID
- REG-P65-01
Available in ToxIntel Enterprise
REACH Planning Assistant
PlannedSubstance registration / evaluation / authorisation / restriction planning support.
- Service
- Regulatory Science
- Industry
- Industrial Chemicals
- ToxIntel module
- REACH Planner (planned)
- Utility ID
- REG-REACH-01
Available through Scientific Consulting
CLP Classification Checklist
PlannedHazard-class assignment and pictogram checklist per EU CLP Regulation.
- Service
- Regulatory Science
- Industry
- Industrial Chemicals · Consumer Products
- ToxIntel module
- CLP Workflow (planned)
- Utility ID
- REG-CLP-01
Available through Scientific Consulting
GHS Label Planning
PlannedGlobally Harmonized System label composition — signal words, pictograms, H/P statements.
- Service
- Regulatory Science
- Industry
- Industrial Chemicals · Consumer Products
- ToxIntel module
- GHS Workflow (planned)
- Utility ID
- REG-GHS-01
Available through Scientific Consulting
SDS Planning Assistant
PlannedSafety Data Sheet section-by-section planning aligned to REACH Annex II / OSHA HCS.
- Service
- Regulatory Science
- Industry
- Industrial Chemicals
- ToxIntel module
- SDS Platform
- Utility ID
- REG-SDS-01
Available through Scientific Consulting
Scientific Intelligence
Literature Search Workspace
PlannedStructured PubMed / regulatory-agency search capture with query provenance.
- Service
- Scientific Intelligence
- Industry
- Legal · M&A · Governance
- ToxIntel module
- Evidence Workspace (planned)
- Utility ID
- SCI-LIT-01
Available through Scientific Consulting
Study Reliability Worksheet
PlannedStructured evaluation of study quality across design, endpoints, and reporting.
- Service
- Scientific Intelligence
- Industry
- Legal · Regulatory Science
- ToxIntel module
- Study Reliability (planned)
- Utility ID
- SCI-REL-01
Available through Scientific Consulting
Klimisch Helper
AvailableKlimisch-scale reliability classification (1–4) with justification prompts. Live via the Aᴳ Hazard Intelligence workspace.
- Service
- Scientific Intelligence
- Industry
- Regulatory Science
- ToxIntel module
- Hazard Intelligence
- Utility ID
- SCI-KLI-01
Available in ToxIntel Enterprise
Evidence Mapping Workspace
PlannedSystematic evidence mapping across ingredient, endpoint, and jurisdiction axes.
- Service
- Scientific Intelligence
- Industry
- Legal · M&A · Governance
- ToxIntel module
- Evidence Workspace (planned)
- Utility ID
- SCI-MAP-01
Available through Scientific Consulting
Scientific Timeline Builder
PlannedChronological ingredient / regulatory / scientific evidence timeline for expert-witness contexts.
- Service
- Scientific Intelligence
- Industry
- Legal & Enforcement
- ToxIntel module
- Timeline Builder (planned)
- Utility ID
- SCI-TML-01
Available through Scientific Consulting
03 — Philosophy
Testing does not create safety.
Interpretation does.
Testing volume is increasing. The differentiator is not how much testing is performed — it is whether the data meaningfully reduces uncertainty and strengthens governance. Before recommending or reviewing any protocol, we define the decision:
- · What uncertainty are we resolving?
- · What claim is being supported?
- · What exposure assumptions govern the product?
- · Would additional data materially change the safety conclusion?
“Testing can be outsourced. Interpretation and documentation cannot.”
04 — Practice lead
Every assessment is signed by a named toxicologist.
No anonymous reports, no offshored interpretation. Aᴳ is led personally by Dr. Augustine K. Agyekum, with specialist advisors engaged per assignment.
Founder · Independent Toxicologist
Augustine K. Agyekum, PhD
"Dr. Kwaku"
Founder of Aᴳ, an independent scientific consulting firm specialising in cosmetic and consumer product safety. Dr. Agyekum advises brands, manufacturers, and legal teams on ingredient safety, quantitative risk assessment, and compliance with FDA MoCRA, the EU Cosmetics Regulation, IFRA standards, and California Prop 65 — translating complex toxicological data into clear safety decisions.
Advisory roster
Aᴳ engages specialist advisors on a per-assignment basis — drawing on board-certified toxicologists, regulatory scientists, and analytical chemists when an engagement warrants additional depth. Roster details available on request.
05 — Engage
We take a small number of new engagements each quarter.
Send a short brief — product, jurisdictions, timeline, and the regulatory question that prompted the call. We respond within two business days.
Direct line
regulatory@tagc.us linkedin.com/company/the-agyekum-groupPractice
The Agyekum Group (AG)
Independent toxicology
Engagements
Cosmetics · Personal care
Ingestibles · Fragrance
Jurisdictions
EU · UK · US (FDA / MoCRA)
California Prop 65 · APAC
Platform
Platform Access →06 — Toxicology Watch
Regulatory intelligence, continuously curated across regulated industries.
Updated 0m ago
Aggregated from the public regulatory record — FDA, CPSC, EPA, OEHHA (California Proposition 65), the FTC, MHRA, OPSS (UK), and the U.S. Federal Register. Curated to surface the documents that meaningfully shape exposure, claim substantiation, and enforcement posture across cosmetics, personal care, consumer products, medical devices, pharmaceuticals, industrial chemicals, and environmental health.
Sources · FDA Cosmetics · CPSC · Proposition 65 · Consumer Protection · Cosmetics · Toxic Substances · Hazardous Materials · Environmental Protection · Medical Devices · UK Medicines & Devices · Drugs · Chemicals · EPA (agency-wide) · UK Office for Product Safety & Standards
- MHRA · UK Medicines & DevicesSep 15, 2026Official Statistics: Quarterly reports on the import of unlicensed medicines
Details and statistics on the import of unlicensed medicines from March 2014 onwards.
Read source - FTC · Consumer ProtectionSep 15, 2026FTC Publishes Price Transparency FAQs for Auto Dealers
Staff of the Federal Trade Commission today published frequently asked questions on price transparency to help the automobile industry comply with the FTC Act.View Press Release
Read source - MHRA · UK Medicines & DevicesSep 15, 2026MHRA and Malaysia strengthen partnership on healthcare innovation and research
The MHRA has reaffirmed its commitment to strengthening regulatory collaboration with Malaysia following high-level discussions in Kuala Lumpur.
Read source - Federal Register · Environmental ProtectionSep 15, 2026Bacillus amyloliquefaciens strain AT-332; Exemption From the Requirement of a Pesticide Tolerance
This regulation establishes an exemption from the requirement of a tolerance for residues of Bacillus amyloliquefaciens strain AT-332 in or on all food and feed commodities when used in accordance with label directions…
Read source - MHRA · UK Medicines & DevicesSep 14, 2026Send and receive information on adverse drug reactions (ADRs)
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Read source - MHRA · UK Medicines & DevicesSep 14, 2026Field Safety Notices: 7 September to 11 September 2026
List of Field Safety Notices from 7 September to 11 September 2026.
Read source - OPSS · UK Office for Product Safety & StandardsSep 14, 2026OPSS community funding for product safety
Information and application forms for organisations seeking to deliver community-based and/or consumer-focused product safety awareness and education projects.
Read source - Federal Register · EPA (agency-wide)Sep 14, 2026Request for Information on Test Methods for Evaluating Solid Waste (SW-846), Waste Sampling and Toxicity Characteristic Leaching Procedure (TCLP) Testing
EPA updates test methods and waste sampling guidance as part of routine updates according to the Resource Conservation and Recovery Act (RCRA). To aid in the implementation of these directives, the Office of Resource…
Read source - Federal Register · Environmental ProtectionSep 14, 2026Approval and Promulgation of State Air Quality Plans for Designated Facilities and Pollutants; District of Columbia; Negative Declaration for Existing Other Solid Waste Incinerators
The Environmental Protection Agency (EPA) is proposing to approve the negative declaration submitted by the District of Columbia Department of Energy and Environment (DCDOEE) on May 21, 2026. The negative declaration…
Read source - Federal Register · Environmental ProtectionSep 14, 2026Clean Data Determination; 1997 8-Hour Ozone Standards; California; Sacramento Metro Area
The U.S. Environmental Protection Agency (EPA or "Agency") is proposing to issue a clean data determination (CDD) for the Sacramento Metro, California nonattainment area to reflect our finding that the area is attaining…
Read source - Federal Register · Environmental ProtectionSep 14, 2026Approval and Promulgation of State Air Quality Plans for Designated Facilities and Pollutants; Maryland; Negative Declaration for Existing Other Solid Waste Incinerators
The Environmental Protection Agency (EPA) is proposing to approve the negative declaration submitted by the Maryland Department of the Environment (MDE) on April 17, 2026. The negative declaration submitted by MDE…
Read source - Federal Register · Medical DevicesSep 11, 2026Medical Devices; Cardiovascular Devices; Classification of the Cardiovascular Machine Learning-Based Notification Software
The Food and Drug Administration (FDA) is classifying the cardiovascular machine learning-based notification software into class II (special controls). The special controls that apply to the device type are identified…
Read source - FTC · Consumer ProtectionSep 10, 2026FTC Publishes Proposed 2027 Budget for Horseracing Integrity and Safety Authority
The Federal Trade Commission is seeking comment on the Horseracing Integrity and Safety Authority’s proposed 2027 budget as submitted to the Commission and published in the Federal Register.View Press Release
Read source - Federal Register · Medical DevicesSep 10, 2026Medical Devices; Cardiovascular Devices; Classification of the Mechanical Deviation Device for Esophageal Protection During Cardiac Ablation Procedures
The Food and Drug Administration (FDA) is classifying the mechanical deviation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to the…
Read source - Federal Register · Medical DevicesSep 10, 2026Medical Devices; Cardiovascular Devices; Classification of the Temperature Regulation Device for Esophageal Protection During Cardiac Ablation Procedures
The Food and Drug Administration (FDA) is classifying the temperature regulation device for esophageal protection during cardiac ablation procedures into class II (special controls). The special controls that apply to…
Read source - Federal Register · Medical DevicesSep 10, 2026Medical Devices; Cardiovascular Devices; Classification of the Extravascular Support for an Arteriovenous Fistula for Vascular Access
The Food and Drug Administration (FDA) is classifying the extravascular support for an arteriovenous fistula for vascular access into class II (special controls). The special controls that apply to the device type are…
Read source - OPSS · UK Office for Product Safety & StandardsSep 9, 2026Designated standards: new or amended notices of publication
Proposed updates to the lists of standards for businesses.
Read source - OPSS · UK Office for Product Safety & StandardsSep 9, 2026Statutory guidance: Simple Pressure Vessels (Safety) Regulations 2016
Guidance for businesses.
Read source - OPSS · UK Office for Product Safety & StandardsSep 9, 2026Guidance: Primary Authority determination process
Information and determination summaries.
Read source - FTC · Consumer ProtectionSep 9, 2026FTC Withdraws Obsolete Policy Statement
Commission takes action to rescind unnecessary 2021 guidance document The Federal Trade Commission rescinded the 2021 Policy Statement on Breaches by Health Apps and Other Connected Devices.View Press Release
Read source - FTC · Consumer ProtectionSep 8, 2026FTC Takes Action Against Payment Processor Humboldt Merchant Services for Knowingly Facilitating Payment Processing for Sham Merchants
Under proposed order, defendant will be required to pay $12 million, stop payment processing for certain categories of merchants Payment processing company Humboldt Merchant Services will pay $12 million and be…
Read source - OEHHA · Proposition 65Sep 3, 2026Announcement of the Carcinogen Identification Committee Meeting Scheduled for November 17, 2026
September 4, 2026 Public Comments Date Friday, September 4, 2026 - 12:00pm - Monday, October 19, 2026 - 12:00pm Meeting Date Tuesday, November 17, 2026 - 10:00am - Tuesday, November 17, 2026 - 05:00pm OEHHA will convene…
Read source - Federal Register · CPSCSep 3, 2026Notice of Availability and Request for Comment: Revision to the Voluntary Standard for Products Containing Button Cell or Coin Batteries
The U.S. Consumer Product Safety Commission's (Commission or CPSC) mandatory rule, Safety Standard for Button Cell or Coin Batteries and Consumer Products Containing Such Products, incorporates by reference UL 4200A,…
Read source - Federal Register · ChemicalsAug 26, 2026Significant New Use Rules on Certain Chemical Substances (24-5.5e)
EPA is issuing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to an Order…
Read source
Ecosystem architecture
Authority
AG Consulting
Independent scientific governance, toxicological evaluation, and regulatory interpretation — signed by a named toxicologist.
tagc.us
Enterprise infrastructure
ToxIntel Platform
Enterprise toxicology intelligence infrastructure — exposure assessment, contaminant surveillance, and compliance documentation for brands and retailers.
toxintel.tagc.usConsumer distribution
GlowCheck Consumer App
Consumer-facing distribution layer of the broader Aᴳ ecosystem. Operated and positioned separately from enterprise infrastructure.
getglowcheck.app