Specialized regulation: This is our business
With more than 25 years of expertise SmartTox combines advanced toxicology, risk assessment and regulatory strategy to accelerate registrations and expand markets.
What we do
We support companies in critical stages of the development and regulatory process, from predictive studies and risk assessments to the structuring of dossiers, compliance with requirements and registration strategy.
R&D Support; and Predictive Studies
- Theoretical toxicological screening
- QSAR / SAR
- Toxicological pre-classification
- Evaluation of the most toxic
- Technical opinion on structure and activity
Regulatory Support - Agrochemicals
- Dietary risk assessment
- Occupational risk assessment
- Environmental risk assessment
- Meeting technical requirements
- PATE, FLORA, DCIPA, leaflet, protocol, registration and prioritization
Regulatory Support - Biologicals
- Safety and biological specificity
- Environmental risk assessment
- Persistence and non-target organisms
- Structuring the technical dossier
- Regulatory strategy for registration and expansion
Regulatory Support - Sanitizers
- Risk assessment
- Theoretical calculation of LD50
- Laboratory studies
- Registration, amendment and revalidation
- Technical-scientific opinion
Risk assessments
- Occupational risk
- Dietary risk
- Environmental risk
- Non-dietary exposure
- Toxicological parameters
Laboratory Monitoring and Evaluation
- Accompanying studies
- Laboratory audits
- Technical design
- Evaluation of toxicological studies
- Evaluation of ecotoxicological, mutagenic and physicochemical studies
Registration Strategy and Dossier
- Regulatory strategy
- Organization of the dossier
- Responding to demands
- Technical arguments
- Building a regulatory rationale
Technical and regulatory training
- QSAR / SAR
- GLP
- Five-batch
- Occupational risk assessment
- Dietary risk assessment
Global presence
We operate in strategic markets with local regulatory control
Our differentials
We combine technical depth, regulatory vision and strategic organization to support processes with greater consistency, clarity and predictability.
Anticipation of Demands
We act preventively, with full knowledge of the technical requirements of the regulatory bodies, minimizing risks, rework and delays in the process.
Solid and Consistent
Dossiers structured to reduce requirements and speed up approvals with a robust scientific basis.
Various areas of activity
Toxicology + regulation + applied chemistry in an integrated and specialized team.
LATAM Experience
Documented success in Argentina, Paraguay, Colombia, Chile and other strategic markets.
Total Predictability
Structured processes, fewer surprises, less rework and no unnecessary cycles.
Regulatory Security
All documents prepared with scientific and legal alignment for maximum compliance.
Continuous monitoring
We don't just deliver reports. We follow the entire regulatory journey through to approval.
25+ Years of Expertise
Consolidated experience in regulatory toxicology and product registration in global markets.
Sectors served
Specialized expertise for different regulated segments
Your product can move forward faster and with less risk
Who we are
SmartTox is a consultancy specializing in regulatory toxicology and regulatory strategy, working with companies operating in regulated markets such as agrochemicals, biologicals and sanitizers.
SmartTox brings together experts in toxicology, applied chemistry, regulatory science, human exposure and environmental risk, with experience in GLP processes, OECD guidelines, OPPTS, among others, and global registration processes.
We work hand in hand with internal regulatory teams to deliver precision, security and strategies that speed up approvals, turning technical complexity into opportunities.
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