Laboratory Monitoring and Evaluation

Your laboratory studies with quality, consistency and regulatory acceptance

We monitor studies and laboratories with a focus on quality, methodological coherence and technical soundness for regulatory processes.

Unattended laboratory studies create risks

Hiring laboratories without checking GLP/OECD compliance results in studies not being accepted by ANVISA, MAPA or IBAMA, generating duplicate costs.

Toxicological and ecotoxicological studies with methodological flaws are only discovered during the regulatory body's analysis, when it is too late to correct them without impacting on the timetable.

Overburdened internal teams are unable to monitor each stage of the study, losing visibility over the quality of the data that will form the basis of the registration dossier.

How SmartTox solves

We act as an extension of your regulatory team, monitoring every stage of laboratory studies with GLP rigor. Our team has extensive experience in managing pre-clinical research CROs and the first AAALAC accreditation in Brazil.

Detailed services

Follow-up studies:

Continuous monitoring of the in vitro and in vivo stages with the executing laboratory, ensuring adherence to the protocols and the quality of the data generated.

Laboratory Auditing:

Quality audit and definition of criteria for contracting laboratories, checking compliance with GLP, OECD and Brazilian and international regulatory requirements.

Technical Outline:

Planning and outlining the studies required for the registration dossier, optimizing the data package and avoiding redundant or insufficient studies.

Evaluation of Toxicological Studies:

Critical analysis of toxicological studies (acute, sub-chronic, chronic, reproductive) to meet Phase 2 requirements and substantiate the dossier.

Evaluation of Ecotoxicological, Mutagenic and Physical-Chemical Studies:

Technical review of ecotoxicological, mutagenicity and physical-chemical studies of formulated and technical products, ensuring consistency and regulatory acceptability.

Why SmartTox

Responsible for the first AAALAC accreditation in Brazil.

Auditing according to GLP/INMETRO/CGCRE and OECD.

Experience in managing pre-clinical research CROs.

11+ articles published in indexed toxicology journals.