Regulatory area

Our team is characterized by its extensive experience in the regulatory field, a deep knowledge of the regulations of each country and excellent academic training. Our work is focused on reducing registration times by detecting and avoiding potential problems from an early stage and / or proposing solutions to existing problems.
To meet this objective, Bioacting provides the following services:
Technical advice on strategy planning.
Review of preliminary studies: Pre-screening, structural elucidation of impurities, evaluation of chemical and / or toxicological equivalence.
Analysis and modifications of the manufacturing process in case of detecting impurities that are not present in the reference, variability in the results or any other problem that threatens the chemical equivalence
Review of five batch studies (Five Batch analysis)
Review of physicochemical studies.
Review of toxicological studies.
Generation of confidential information: justification of impurities, declaration of composition, degradation products methodology, among others.
Adaptation of existing information to the regulations of each country.

formulations

Applying the knowledge and needs of the market we have developed innovative formulations either by the type of formulation or by the identity of the active principles used.
Development of innovative formulations
Mixture of active principles
Formulation improvement
Production process
Stability studies
Field tests
Performance test
Efficacy tests
Residue tests and studies

Support area

We accompany the registering company throughout the registration process throughout the different stages
Generating the best strategy for the registry
Evaluation of current patents.
Analyzing and approving study plans, reports and confidential information for both technical product and formulated product.
Total interaction with the laboratories during the execution of the study.
Responses to demands.
Adequacy of studies in case of modifications of the existing regulation.

Training

We have personnel trained in various areas to address the following issues:
Good laboratory practices, preparation of standardized procedures, study plans, records and related documentation.
Processes of registration by equivalence.
Development and validation of analytical methodologies.
Five batch studies.
QSAR and SAR
Structural elucidation using spectroscopic methods.

Predictive toxicology

We carry out QSAR studies under various regulations among the most complete are the Directive Brazilian and the European.
As a result of our dedication and work, our studies have had a high acceptance rate (100%) both in Brazil, Mexico, Argentina and Europe.
We have experience in various assets and their impurities, In recent months we have worked on the following projects: Azoxystrobin, Lufenuron, Cyproconazole, Picoxistrobin, Diflubenzuron, Methoxyfenozide, Fomesafen, Metamitron, Carfentrazone-ethyl, Chlorpyrifos, Indoxacarb, Chlorantraniliprole, among others.

Experience and emblematic cases

We are the first company that has obtained an equivalence registration in Argentina after submitting a QSAR study.
We are an active part of the Task-Force formed to re-assess the Abamectin registry in Brazil.
In 2012 we became the first company that was able to reverse a definitive disapproval in Brazil.
We actively worked on training in GLP standards and the development of five-batch in two well-known laboratories at a national level.

Five Batches training and implementation

Personnel training: Regulatory affairs, GLP, development of methodologies, execution of screening and five batches studies, structural elucidation, equipment management (HPLC / GC / IR among others.), etc. .
Generation of various documents according to good laboratory practices (study plan, procedures, tables, instructions, etc).
Implementation in the laboratory and generation of studies.
Project monitoring and full support in the generation of studies.