Dicentra
Dicentra is a contract research organization and professional consulting firm dedicated to addressing safety, quality, and compliance across the life sciences and food industries. Since 2002, it has completed over 18,000 projects for more than 1,200 international clients. The company's mission is to provide result-oriented regulatory and scientific solutions that promote accelerated business growth and long-term strategic partnerships, with a vision to accelerate innovation and improve global quality of life. Dicentra values innovation, transparency, integrity, and respect, and offers services including life sciences consulting, food safety and quality consulting, global certifications, clinical trials, and medical device compliance services.
Industries
Nr. of Employees
small (1-50)
Products
Regulatory & Strategy
Comprehensive regulatory and strategy consulting services to help products and operations gain market access and ensure compliance across cosmetic, food, beverage, medical device, OTC medication, supplement, health product, and veterinary industries.
GRAS Consulting and Regulatory Strategy
Expert-led GRAS determinations and regulatory strategy services for food, beverage, and nutraceutical ingredients entering the U.S. market.
FDA Product
FDA regulatory consulting services for companies involved in the manufacturing, packaging, labeling or holding of dietary supplements for distribution in the United States.
FDA Product Classification
Assistance in classifying products based on ingredients, claims, and application to establish a pathway to authorization and marketing under FDA regulations.
Food Supplement
Nutrivigilance and adverse event/adverse reaction reporting services to assess the risk-to-benefit ratio of food supplements and ensure compliance with European market nutrivigilance schemes.
Food Supplement Regulatory Services for the European Union
Regulatory consulting services offered by Dicentra to help get food supplements to market in the European Union.
Regulatory & Strategy
Comprehensive regulatory and strategy consulting services to help products and operations gain market access and ensure compliance across cosmetic, food, beverage, medical device, OTC medication, supplement, health product, and veterinary industries.
GRAS Consulting and Regulatory Strategy
Expert-led GRAS determinations and regulatory strategy services for food, beverage, and nutraceutical ingredients entering the U.S. market.
FDA Product
FDA regulatory consulting services for companies involved in the manufacturing, packaging, labeling or holding of dietary supplements for distribution in the United States.
FDA Product Classification
Assistance in classifying products based on ingredients, claims, and application to establish a pathway to authorization and marketing under FDA regulations.
Food Supplement
Nutrivigilance and adverse event/adverse reaction reporting services to assess the risk-to-benefit ratio of food supplements and ensure compliance with European market nutrivigilance schemes.
Food Supplement Regulatory Services for the European Union
Regulatory consulting services offered by Dicentra to help get food supplements to market in the European Union.
Services
Scientific and regulatory evaluation, case report preparation, record maintenance, regulatory reporting, SOP creation and training for adverse event intake and processing.
End-to-end clinical research support including protocol development, study design, feasibility assessment, site selection, monitoring, recruitment strategy and clinical bioanalytics.
Compilation and submission support for regulatory filings across jurisdictions, including GRAS/NDI notifications, feed registrations and device listings.
Review and remediation of product listings, certificates, labels and claims to meet platform policies and seller requirements for food, cosmetics, medical devices and other regulated products.
Assistance with device registration, 510(k) clearance and PMA preparation, label development, medical device reporting support and coordination with regulatory authorities to enable listing and market access.
Product classification, ingredient and formula review, label and packaging compliance, coordination of required testing and clinical evaluation for cosmetics and personal care products.
Scientific and regulatory evaluation, case report preparation, record maintenance, regulatory reporting, SOP creation and training for adverse event intake and processing.
End-to-end clinical research support including protocol development, study design, feasibility assessment, site selection, monitoring, recruitment strategy and clinical bioanalytics.
Compilation and submission support for regulatory filings across jurisdictions, including GRAS/NDI notifications, feed registrations and device listings.
Review and remediation of product listings, certificates, labels and claims to meet platform policies and seller requirements for food, cosmetics, medical devices and other regulated products.
Assistance with device registration, 510(k) clearance and PMA preparation, label development, medical device reporting support and coordination with regulatory authorities to enable listing and market access.
Product classification, ingredient and formula review, label and packaging compliance, coordination of required testing and clinical evaluation for cosmetics and personal care products.
Expertise Areas
- Clinical trial management
- Site qualification and trial monitoring strategies
- Clinical biostatistics and data analysis
- Pharmacovigilance and adverse event reporting
Key Technologies
- Clinical trial management methodologies
- Risk‑based monitoring and SDV approaches
- Biostatistical analysis and study design tools
- Preclinical and clinical bioanalytical assays
News & Updates
On June 2, 2025, the FDA launched Elsa, a generative AI tool to assist with regulatory functions.
A comparison of clinical trial monitoring approaches to optimize patient safety and data integrity.
Pre-trial assessments to ensure smooth clinical trial execution.
Discussion on regulatory changes affecting GRAS status and innovation.
Health Canada has launched a consultation on a proposed regulatory pathway for health products containing cannabidiol (CBD) that would allow access without a prescription.
Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) has announced a major shift in how Class III Natural Health Product (NHP) submissions will be reviewed.
On June 2, 2025, the FDA launched Elsa, a generative AI tool to assist with regulatory functions.
A comparison of clinical trial monitoring approaches to optimize patient safety and data integrity.
Pre-trial assessments to ensure smooth clinical trial execution.
Discussion on regulatory changes affecting GRAS status and innovation.
Health Canada has launched a consultation on a proposed regulatory pathway for health products containing cannabidiol (CBD) that would allow access without a prescription.
Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) has announced a major shift in how Class III Natural Health Product (NHP) submissions will be reviewed.