Dicentra

What Dicentra does

Dicentra is a Toronto-based contract research organization (CRO) and professional consulting firm founded in 2002, serving the life sciences and food industries across the US, Canada, and European Union. The company operates through four divisions — Life Sciences Consulting, Food Safety & Quality Consulting, Clinical Trials, and Global Certifications (dicentra GC, an ANSI ISO 17065 accredited certification body) — offering an integrated CRO-plus-regulatory-consulting model that allows clients to consolidate vendor relationships across product development, market authorization, clinical research, and post-market compliance.

The core service portfolio spans Phase I–IV clinical trials (protocol design, site monitoring at the firm's own Toronto clinical site, bioanalytics using UPLC/MS/MS, pharmacovigilance, biostatistics, and regulatory submissions), regulatory affairs across FDA, Health Canada, and EFSA frameworks (GRAS, NDIN, NHP licensing, novel food submissions, 510(k), CE Mark), food safety and quality systems (HACCP, GFSI, FSMA, SQF, BRCGS, FSSC 22000), product and label development, advertising clearance, adverse event reporting, and M&A due diligence. The firm maintains specialized methodology in probiotic trial design and point-of-care diagnostic validation, with documented experience of 23,000+ projects, 450+ clinical trials, 200+ publications, and 1,400+ clients.

Dicentra monetizes exclusively through professional services: project-based consulting fees, CRO study contracts, recurring certification programs, and online training subscriptions via training.dicentra.com. Pricing is quote-based and not publicly disclosed. Go-to-market is sales-led and event-driven, supported by thought-leadership content (blog, webinars, on-site training), industry-association memberships (IPA, Cannabis Council of Canada), and partnerships (AIDP, Nutritional Capital Network, Rize Health). The firm employs 51–100 staff and is privately held under founder and CEO Alicja Wojewnik, with no disclosed external institutional investment.

Name

Dicentra

Legal name

dicentra

Website

https://dicentra.com

Company type

Private

Founded year

2002

Operating status

Operating

Headcount range

51–100 employees

Short description

Dicentra is a Toronto-based CRO and regulatory consulting firm founded in 2002, providing integrated clinical trial, regulatory affairs, food safety, and certification services to life sciences and food industry clients across North America and Europe.

Ownership category

akta.pro rank

Product category

Regulatory Consulting & Contract Research Services

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Scientific Research and Development Services (5417), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Management Services (8741)

akta.pro industry

PRIMARYHLAGAAAA

Clinical CROs (Phase I–IV)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

SECONDARYHLAGAKAA

Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Regulatory Affairs, Quality & Compliance Services (GxP)

SECONDARYHLAGAAAH

Pharmacovigilance, Risk Management & Medical Affairs CROs

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Contract Research Organizations (CRO)

SECONDARYAFALADAC

Regulatory Consulting & Compliance Program Management (FDA/USDA/EFSA)

Agriculture & Food Production/Food Safety, Testing & Certification/Regulatory Compliance Testing & Consulting (FDA/USDA/EFSA, HACCP)

SECONDARYHLAIALAH

Regulatory Strategy & IND/NDA/BLA Submissions Support

Healthcare & Life Sciences/Pharmaceuticals/Pharmaceutical Research and Development

Keywords

• Regulatory consulting services
• Contract research organization
• Clinical trial management
• Food safety consulting
• Regulatory affairs support

Headquarters

HQ city

Toronto

HQ country

Canada

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. Regulatory Consulting Services: Professional consulting fees for regulatory affairs, compliance strategy, product classification, market authorization, and regulatory submissions across food, supplement, cosmetic, pharmaceutical, and medical device industries in the US, Canada, and EU markets.
2. Clinical Trial Services: Full-service CRO offerings including protocol development, trial management, site monitoring, participant recruitment, pharmacovigilance, bioanalytics, and biostatistics for Phase I-IV trials across natural health products, dietary supplements, functional foods, cosmetics, medical devices, and pharmaceuticals.
3. Training & Education Services: On-site and online training programs for GMP compliance, HACCP, food safety, regulatory requirements, and certification preparation. Includes GMP Online Training for Dietary Supplements (21 CFR Part 111) and GMP Online Training for Natural Health Products (Canada).
4. Due Diligence Services: Regulatory due diligence assessments for mergers and acquisitions, evaluating compliance status, product portfolios, and risk liabilities for transactions in the food and wellness categories.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels5 records

Core offering

Dicentra is a contract research organization (CRO) and professional consulting firm offering integrated regulatory consulting and clinical research services to life sciences and food industries. Services span market authorization, quality and safety compliance, clinical trial management (Phase I-IV), auditing, product and label development, adverse event reporting, training, and due diligence across pharmaceuticals, medical devices, cosmetics, natural health products, dietary supplements, food and beverages, animal feed, and consumer products for USA, Canada, and EU markets.

Product overview

Dicentra is a contract research organization (CRO) and professional consulting firm organized around four business divisions: Life Sciences Consulting, Food Safety & Quality Consulting, Clinical Trials, and Global Certifications. The core offering consists of integrated regulatory consulting and clinical research services for the life sciences and food industries, covering product development, market authorization, quality assurance, and post-market compliance. The Clinical Trials division provides full-service Phase I-IV clinical research services spanning protocol design, site selection, recruitment, monitoring, bioanalytics, pharmacovigilance, biostatistics, and regulatory submissions. The Life Sciences Consulting and Food Safety & Quality divisions deliver regulatory strategy, auditing, product/label development, advertising clearance, adverse event reporting, training, and market access services across multiple industry verticals including pharmaceuticals, medical devices, cosmetics, dietary supplements, natural health products, food & beverages, animal feed, and consumer products. Regional services cover USA, Canada, and European Union markets. The company operates its own clinical trial site in Toronto and provides both on-site and online training through its training platform.

Differentiator

Problem solved

Functional benefit

Products and services

• Clinical Trials (Phase I-IV CRO Services) Full-service contract research organization (CRO) providing clinical trial services for Medtech, Pharma, Wellness, and Food industries, covering protocol development, participant recruitment, regulatory submissions, trial monitoring, bioanalytics, pharmacovigilance, biostatistics, and statistical analysis across Phase I-IV, supported by a Toronto-based clinical site.
• Life Sciences Consulting Regulatory and scientific consulting services helping companies develop compliant life sciences products, including market authorizations, quality assurance, safety and toxicology support, product development, auditing, advertising review, clinical trial design, adverse event reporting, and training.
• Food Safety & Quality Consulting Food safety and quality management consulting providing HACCP, GFSI, SQF, FSSC 22000 certification readiness, food safety audits, FSMA and SFCA expertise, quality management systems, supplier verification, gap analysis, risk assessment, and food defense program development for food and beverage manufacturers in North America.
• dicentra Global Certifications ANSI ISO 17065-accredited certification body operating as an operating division of Dicentra (dicentra GC), licensed by CFIA to issue certifications under the Safe Food for Canadians Regulations (SFCR).
• Acquisition & Vendor Due Diligence In-depth regulatory compliance assessment for mergers and acquisitions, including documentation review, process assessment, risk identification, and liability evaluation for transactions in food and wellness categories (involved in transactions exceeding $700 million).
• USA Regulatory Services US regulatory consulting including product strategy, food safety, dietary supplements, cosmetics, NDI notifications, OTC drugs, medical devices, advertising review, adverse event reporting, and regulatory due diligence.
• Canada Regulatory Services Canadian regulatory consulting including product strategy, food compliance, NHP regulatory, cosmetics, OTC drugs, consumer health, medical devices, novel food submissions, adverse reaction reporting, and regulatory due diligence.
• European Union Food Supplement Services EU food supplement regulatory services including classification, ingredient safety review, labeling compliance, claims review, dossier preparation, product registration, novel food submission, and nutrivigilance.
• Online Training Platform Online learning platform offering GMP Online Training for Dietary Supplements (21 CFR Part 111), GMP Online Training for Natural Health Products (Canada), and HACCP Online Training.
• On-site Training & Education Customized employee training in quality processes including HACCP training, GFSI scheme development, GMP training for NHPs, cGMP training for dietary supplements, FDA and Canada food labeling requirements, and NHP labeling requirements.
• Media Representation Professional media representation on safety, quality and compliance matters including medical doctor representation for radio, television, print, expert panels, lectures, product introductions, social media content development, and webinar representation.

Quantifiable outcome

• 23,969+ projects completed for clients worldwide
• +4 more outcomes

Named customers5 records

Segments9 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Four partnerships are on record, tiered minor.

• AIDP Inc.minorGTM or Marketing Partner · 13 September 2021Dicentra partnered with AIDP Inc. as the exclusive partner for 'The Future of Health and Wellness – From Personalized Nutrition to Artificial Intelligence' virtual event. AIDP is a nutritional ingredients supplier.
• Cannabis Council of CanadaminorOthers · 14 May 2021Dicentra Cannabis & Psychedelics Consulting (dCC) became an affiliate member of the Cannabis Council of Canada, providing regulatory consulting for cannabis and psychedelics.
• Nutritional Capital Network (NCN)minorGTM or Marketing Partner · 28 September 2020Dicentra joined NCN as their exclusive clinical research partner, connecting with investment community and nutrition industry stakeholders.
• International Probiotics Association (IPA)minorOthers · 7 February 2020Dicentra maintains membership in the International Probiotics Association, an industry organization supporting probiotic companies and regulatory standards.

Scale indicators12 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Celerion: Celerion specializes in early-phase clinical research, including bioanalytical services, PK/PD studies, and first-in-human trials, similar to Dicentra's early-phase Phase I-IIa capabilities. It is a strong direct comparable in clinical pharmacology and bioanalytics.
• NSF International: NSF provides food safety, dietary supplement, and regulatory certification/testing services across the US, Canada, and EU. It is one of the most direct comparables to Dicentra's food safety and supplement regulatory practices.
• Mérieux NutriSciences: Mérieux NutriSciences delivers food safety, quality, and regulatory services globally, including testing, auditing, and consulting for food and consumer products. Directly comparable to Dicentra's Food Safety & Quality division.

Broad incumbents

• Eurofins Scientific: Eurofins provides laboratory testing and regulatory-support services across food, pharma, and consumer products worldwide. It overlaps with Dicentra's bioanalytical, food safety, and quality testing capabilities but operates a much larger network of labs.
• Bureau Veritas: Bureau Veritas is a global testing, inspection, and certification company with strong food and consumer product service lines. It competes with Dicentra in food safety audits, HACCP, GFSI, and supply-chain compliance work.
• Labcorp Drug Development (formerly Covance): Labcorp Drug Development is a top-tier global CRO offering full-service clinical, bioanalytical, and central lab services. It competes with Dicentra in clinical trial execution, bioanalytics, and central lab services, but at vastly greater scale and global reach.
• Intertek: Intertek is a global testing, inspection, and certification giant with extensive food, supplement, and pharmaceutical services. It overlaps with Dicentra's regulatory, food safety, and quality testing offerings, but at significantly greater scale and breadth.
• SGS: SGS is one of the world's largest testing, inspection, and certification companies, with significant food, life sciences, and pharmaceutical service lines. Comparable to Dicentra across food safety, quality, and regulatory consulting, though at a vastly larger global scale.
• Charles River Laboratories: Charles River is a major preclinical and clinical CRO serving pharma and medical device companies. Comparable to Dicentra's Clinical Trials division, especially for preclinical, early-phase, and safety assessment work, though at far greater scale.

Emerging players

• Inotiv: Inotiv provides preclinical and clinical research services, with a focus on early-stage drug and device development. It overlaps with Dicentra's preclinical and early-phase clinical offerings, though it is more focused on animal models and device safety.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCf66rl_iMRb_pTspTdY9zQQ/videos
• LinkedInlinkedin.com/company/dicentra
• Xx.com/dicentradotcom

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 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 Dicentra