Regulatory Support - Biologicals

Registration of biologicals with a scientific strategy and regulatory vision

With the biopesticides sector booming in Brazil, your company needs specialized support. We offer the science and regulatory rigor needed to accelerate registrations and safely consolidate your growth.

Registering biologics requires a different approach

The registration of biological products follows a different regulatory logic from conventional agrochemicals. Companies that apply the same approach face unexpected requirements and significant delays.

Evaluating the safety and specificity of microorganisms requires expertise in microbiology, ecotoxicology and regulation - a set rarely brought together in a single consultancy.

With Law 15.070/2024 and Joint Ordinance SDA/MAPAP - IBAMA - ANVISA 01/2023 speeding up processes, companies that aren't prepared are missing out on a window of competitive opportunity.

How SmartTox solves this

We combine expertise in microbiology, regulatory toxicology and registration strategy to take your biological products from the laboratory to the market with absolute scientific rigor. Our strategic performance is strengthened by an active presence at the Biological Summit and by alliances with global experts in the sector.

Detailed services

Safety and Biological Specificity:

Evaluation of the safety profile of the microorganism or biological control agent, including the tests required by Joint Ordinance SDA/MAPA - IBAMA - ANVISA 01/2023 and Environmental Risk Assessment

Environmental Risk Assessment:

Analysis of the environmental impact of the biological product, considering specificity of action, persistence in the environment and effects on non-target organisms. Meeting IBAMA's requirements on a scientific basis.

Evaluation of Agronomic Efficiency:

Analysis of the experimental field protocol, with the entity accredited by MAPA for field tests, in accordance with Normative Instruction 36/2009, with updates to Normative Instruction 42/2011/SDA/MAPA.

Persistence and non-target organisms:

Studies and evaluations on the persistence of the biological agent in the environment and its potential effects on auxiliary fauna and flora, demonstrating the environmental safety profile required by the authorities.

Structuring the Technical Dossier:

Complete organization of the registration dossier with all the required studies, data and documentation, structured in a logical, defensible way and in line with the expectations of the evaluating bodies.

Regulatory Strategy for Registration and Expansion:

Defining the most efficient regulatory route for your biological product, taking into account the particularities of Brazilian regulations, Law 15.070/2024 and opportunities for expansion into other LATAM markets.

Why SmartTox

Active participation in the biologicals market (Biological Summit, Syntech).

Multidisciplinary team: microbiology, toxicology and regulatory.

Knowledge of the accelerated routes of Law 15.070/2024.

International partners for LATAM expansion.

Close involvement in regulatory discussions, with direct monitoring of the evolution of the Bioinputs Decree and other milestones applicable to the sector.