What Intrinsik does

Intrinsik Corp. is a private, employee-owned scientific and regulatory consulting firm headquartered in Mississauga, Ontario, with additional offices in Calgary (Alberta), Venice (California), and Research Triangle Park (North Carolina). Founded in January 2007 by Mike Luksic, the firm provides toxicology, human health risk assessment, ecological risk assessment, and regulatory affairs services to pharmaceutical and biotechnology companies, chemical manufacturers, consumer product firms, government agencies (federal, provincial/territorial), and Indigenous communities across North America. The firm is organized around four service verticals: Pharmaceuticals and Biotechnology, Chemicals and Consumer Products, Environmental Sciences, and Toxicology.

The company's offerings span the full product lifecycle, including regulatory affairs strategy and submissions (CTA, IND, NDA, NDS, MAA), medical writing, CMC, regulatory operations, toxicological risk assessments for impurities, degradants, extractables, leachables, excipients, and nitrosamines/NDSRIs, contaminated sites risk assessment, biomonitoring studies, traditional food studies, health impact assessments, climate-health vulnerability work, emerging contaminants evaluation, and expert testimony. Technical capabilities combine traditional experimental toxicology with FDA-validated in silico tools (Leadscope, Multicase) and QSAR modeling for structural alerts and genotoxicity assessment, plus the IEUBK biokinetic model and contaminant fate/transport modeling. Senior staff cite involvement in over 300 successful INDs and more than 30 NDA approvals, and the firm maintains an in-house toxicology database covering 3,500+ chemicals.

Intrinsik operates as a project-based professional services firm. It sells directly to enterprise and government clients through business development, RFP responses, and standing offers, with the Health Canada Safe Environments Directorate standing offer for human health risk assessment services acting as a recurring anchor. Marketing is limited to corporate website content, LinkedIn presence, conference participation, and peer-reviewed publications rather than paid advertising. The firm is entirely employee-owned, with no external investors, parent entity, or disclosed funding rounds. Source materials report founding dates of both 1985 (cumulative senior experience) and January 2007 (corporate founding), reflecting how the firm positions its institutional experience versus its formal incorporation.

Name

Intrinsik

Legal name

Intrinsik Corp.

Website

https://intrinsik.com

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

101–250 employees

Short description

Intrinsik Corp. is an employee-owned scientific and regulatory consulting firm delivering toxicology, risk assessment, and regulatory affairs services to pharmaceutical, chemical, consumer products, government, and Indigenous community clients across North America.

Ownership category

akta.pro rank

Product category

Regulatory and Toxicology Consulting Services

NAICS

Other Scientific and Technical Consulting Services (541690), Environmental Consulting Services (54162), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

akta.pro primary industry

Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC)

akta.pro secondary industries

Regulatory Consulting & Compliance Program Management (FDA/USDA/EFSA) (AFALADAC), Chemical Management & Toxic Substances Compliance (TSCA, REACH, GHS/SDS, PFAS Programs) (EUAHABAE)

Keywords

• Toxicology consulting
• Regulatory affairs services
• Risk assessment consulting
• Environmental health consulting
• Pharmaceutical regulatory consulting

Headquarters

HQ city

Mississauga

HQ country

Canada

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales

Revenue model

1. Scientific and Regulatory Consulting Services: Intrinsik generates revenue through providing expert consulting services in toxicology, regulatory affairs, environmental risk assessment, and health impact assessment. Revenue is derived from project-based consulting engagements with pharmaceutical companies, chemical manufacturers, government agencies, and industrial clients. Services include regulatory submissions, risk assessments, medical writing, and expert testimony.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels3 records

Core offering

Intrinsik is a scientific and regulatory consulting firm providing toxicology, regulatory affairs, human health and ecological risk assessment, environmental sciences, and medical writing services. The firm serves pharmaceutical, biotechnology, chemical, consumer product, and government clients with services including toxicological risk assessments for impurities and excipients, regulatory submissions (INDs, NDAs, MAAs), contaminated site assessments, biomonitoring, and health impact assessments delivered by Board-certified toxicologists.

Product overview

Intrinsik is a scientific and regulatory consulting firm offering a comprehensive portfolio of services across four primary sectors: Pharmaceuticals and Biotechnology, Chemicals and Consumer Products, Environmental Sciences, and Toxicology. The core offerings include toxicological risk assessments for pharmaceuticals (covering impurities, degradants, extractables, leachables, excipients, nitrosamines/NDSRIs), environmental risk assessments (contaminated sites, excess soil, vapour intrusion, pharmaceuticals), health impact assessments, and regulatory affairs consulting. Medical Writing and Regulatory Operations services support submissions to Health Canada, FDA, EMA, and other regulatory bodies. The firm also provides specialized services including biomonitoring studies, traditional food studies, emerging contaminants assessment, employee health surveys, data sciences, risk communication, and Indigenous community support. These services are delivered by a team of Board-certified toxicologists and environmental scientists, functioning as an integrated consulting offering rather than a software platform.

Differentiator

Problem solved

Functional benefit

Products and services

• Pharmaceuticals and Biotechnology Services Comprehensive regulatory and scientific consulting for pharmaceutical and biotechnology companies, covering regulatory affairs, nonclinical consulting, medical writing, CMC, regulatory operations, and due diligence services to support product development and regulatory submissions.
• Chemicals and Consumer Products Services Consulting services for chemicals and consumer products including LHAMA evaluation, toxicological risk assessments, cosmetic safety assessments, Proposition 65 compliance, product label reviews, and Safety Data Sheet preparation.
• Environmental Sciences Services Environmental consulting services encompassing human health and ecological risk assessment, contaminated sites assessment, health impact assessments, biomonitoring studies, data sciences, toxicological support, risk communication, and Indigenous community environmental support.
• Toxicology Services Strategic regulatory and scientific toxicology guidance including toxicological risk assessments for impurities, degradants, extractables, leachables, excipients, nitrosamines, NDSRIs, and pharmaceutical health and safety evaluations performed by American and European Board-certified toxicologists.
• Regulatory Affairs Consulting Regulatory strategy development and submission management for pharmaceuticals and biologics across Canada, US, and EU markets, including CTA, IND, NDA, NDS, and MAA filings.
• Medical Writing Services Authoring and reviewing clinical and nonclinical sections of regulatory submissions including INDs, CTAs, NDAs, NDSs, MAAs, Investigator's Brochures, CTD Module 2 summaries, protocols, and clinical study reports.
• Regulatory Operations Regulatory publishing and document management services including eCTD and non-eCTD submissions to Health Canada, FDA, and international regulatory authorities, with expertise in electronic and paper formats.
• Pharmaceutical Health and Safety Occupational and environmental pharmaceutical safety services including OEL derivation, HBEL/PDE/ADE/OEL calculations, cleaning validation, childproof packaging F-values, SDS preparation, and ecological risk assessments for pharmaceuticals.
• Human Health and Ecological Risk Assessment Risk assessment services applying contaminant fate and transport modeling, IEUBK modeling for childhood blood lead prediction, and quantitative risk assessment methodologies for human and ecological receptors.
• Federal Contaminated Sites Risk Assessment Science-based risk assessment solutions for federal contaminated sites following FCSAP, Health Canada, and CCME frameworks, including preliminary and detailed quantitative risk assessments (PQRAs and DQRAs).
• Traditional Food Studies Scientific assessments quantifying contaminant concentrations and exposure risks from traditional/country food consumption, integrating Indigenous Knowledge with quantitative analysis to support food sovereignty.
• Human Biomonitoring/Evaluation of Exposure Studies Biomonitoring studies that quantify human exposure to chemicals through biological fluid and tissue analysis (blood, urine, hair, nails), combined with environmental sampling and questionnaire-based exposure assessment.
• Nitrosamine and NDSRI Risk Assessments Comprehensive nitrosamine impurity risk assessments including CPCA for NDSRIs, QSAR-based read-across support, genotoxicity testing support, acceptable intake derivation, and regulatory compliance assistance.
• Health Impact Assessment Health impact assessments examining how projects and policies may affect human health and wellbeing, integrating climate change considerations, Indigenous and community health, and the built environment.
• Emerging Contaminants Assessment Research and evaluation of emerging contaminants including PFAS, 6PPD-quinone, flame retardants, microplastics, and pharmaceutical residues, including literature reviews and toxicity value development.
• Nonclinical Consulting Nonclinical consulting service for drug development programs including toxicology study design, nonclinical safety program planning, and regulatory interactions for INDs and NDAs.

Named customers13 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Broad incumbents

• Stantec: Stantec is a global design and consulting firm with a substantial environmental services practice covering contaminated sites, risk assessment, and regulatory compliance across Canada and the US. Comparable to Intrinsik's environmental sciences portfolio with much larger scale and broader geographic reach.
• Environmental Resources Management (ERM): ERM is a global sustainability and environmental consulting firm with health risk assessment, contaminated sites, and product stewardship capabilities. Overlaps with Intrinsik's environmental risk assessment, chemicals, and emerging contaminants services at materially larger scale.
• Arcadis: Arcadis is a global design and consultancy with a sizable environment and health practice, including contaminated site risk assessment, biomonitoring, and regulatory affairs support. Comparable to Intrinsik's environmental consulting work but operating as a full-service global firm.
• Exponent: Exponent is a large engineering and scientific consulting firm with a significant toxicology, exposure assessment, and regulatory practice. Overlaps with Intrinsik in pharmaceutical, chemical, and consumer product safety engagements but operates at much larger scale across multiple engineering disciplines.
• Charles River Laboratories: Charles River is a major nonclinical CRO providing safety assessment, toxicology, and regulatory support services to pharmaceutical and biotechnology clients. Comparable to Intrinsik's nonclinical consulting and toxicology practice, but at much greater scale with integrated laboratory capabilities.
• Ramboll Environment & Health: Ramboll is a global engineering, environmental, and health sciences consultancy with a strong contaminated sites and human health risk assessment practice. Directly comparable to Intrinsik's environmental sciences and contaminated sites services, though Ramboll offers a much broader portfolio including engineering and sustainability.

Regional players

• GHD: GHD is a global engineering, architecture, and environmental consulting firm with significant Canadian presence offering contaminated sites and environmental risk assessment services. Comparable to Intrinsik's environmental consulting work, primarily competing in the same Canadian geography though GHD serves global markets as well.

Direct peers

• ToxStrategies: ToxStrategies is a private toxicology and risk assessment consulting firm serving pharmaceutical, chemical, and consumer product clients. Directly comparable to Intrinsik's toxicology, regulatory affairs, and product safety assessment practices, with similar board-certified toxicologist bench and project-based delivery model.
• Gradient Analytics: Gradient is a specialized scientific consulting firm focused on toxicology, exposure science, and risk assessment for chemical, pharmaceutical, and consumer product clients. Closely mirrors Intrinsik's chemical and consumer product toxicology practice, including California Proposition 65 work.
• SLR Consulting: SLR is a mid-sized global environmental and advisory consultancy with contaminated site risk assessment, human health, and ecological services. Comparable to Intrinsik's environmental sciences portfolio, with similar mid-market positioning but broader geographic reach.

Market position

Weaknesses4 records

Competitive moat5 records

Key risks7 records

Key highlights6 records

Customer concentration

• LinkedInca.linkedin.com/company/intrinsik-health-sciences-inc.
• Xx.com/intrinsikcorp

Revenue estimate

Valuation estimate

Number of profiles

Profiles14 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Intrinsik