Juan Carlos López
Regulatory Evidence Support
Juan Carlos López
Regulatory Evidence Support
Agrovant
Your supporter for regulatory engineering for pesticides and plant nutrients.
More than 24 years of experience support us to provide exhaustive solutions for the legal product access to the mexican market. Our mission is to merge technical rigor, plan of action and a vast partner network, extending services such as:
🟢 Designing label projects.
🟢 Biological efficacy studies.
🟢 Registration and import permits obtainment.
🟢 Safety assessment (QSAR models).
We convert the regulatory complexity into operational certainty.
Why going for Agrovant?
🟢 More than 24 years of experience on the mexican regulatory system.
🟢 Exhaustive solution 360°: Partner Networking with laboratories (GLP and ISO-17025), researchers and legal and custom specialists.
🟢 Technical-Legal focusing: We look after each project with analytical thinking that assures the success and optimization of the results.
🟢 Full commitment: Firm ethics, utter confidentiality and long-lasting relationships based on reliance and mutual respect.
Classification and regulation of inputs for controlled use in Mexico
In Mexico, pesticides and plant nutrients are strictly under official control, taking as reference their origin and their use. They are regulated according to these categories:
Pesticides
Origin: Chemical Pesticides and Biopesticides.
Uses: Agro, forest, livestock, public health, biocide, urban, gardening and domestic.
Plant Nutrients
Fertilizers: Inorganic, organo-minerals and organic.
Soil Improvers: Inorganic and organic.
Growth Regulators: Type I, II y III.
Inoculants
Wetting Agents
For this reason, the sanitary registration is not just a mere process, yet it becomes the main trade enabler of its own company. It is crucial to, after validating the security and efficacy of their products, obtain the certification to take part in the entire Mexican area. Thus, the compliance becomes the essential base of the market strategy and the step to take for the developing on the country.
Our Portfolio of Services
Exhaustive management of the life process from the product to ensure the regulatory compliance and optimize the access to the Mexican market.
Management of the Life Process from the Sanitary Registration
New Sanitary Registrations in view of COFEPRIS
We implement the full process, from the diagnosis and incorporation of the dossier to the management and tracing towards the authority.
Extension of Sanitary Registrations (Renewals)
We protect your assets managing the renewal of your registrations for 5 years more. To achieve that, we develop an unmistakable dossier and provide tracing until we obtain the resolution.
Modifications to the Registration
We keep the registrations updated to whichever change on the business plan:
Administrative
Assignment of Rights (We carry out the transfer of the ownership).
Updating on the Registration Holder (Change on the Company Name and/or Tax Domicile).
Provider add, drop or change (New provider or change on the Company Name and/or Tax Domicile from the authorized provider).
Updating on the Company name from the Manufacturer, Formulator, or Maquiladora (Updating for official change on the Company Name)
Brands Add, drop or change to the registration.
Methods
Change or Expansion of the Use: We manage the inclusion of new crops, pests or doses on the label.
Setting of the Lifetime or Expiration Date: We manage the modification to the product’s expiration period.
Change on the formulation ingredients: Updating of the inert ingredients used on the formulation.
Change or addition from the manufacturer and/or formulator and/or provider and/or Maquiladora: this type of change is necessary when a new site and/or manufacturing process and/or formulation process exists.
Strategic solutions and to Access the Market
Ownership of the Registration (Registration Holder)
It allows you to create your own registration procedures as soon as possible, not having the need to possess a legally conformed company in Mexico. The service includes the holding of the dossier, legal representation and a clear process to the future assignment of rights to your own establishment.
The Label as and Strategic Tool of Business
The label achieves a triple critical function, as a legal contract, a user guide and a selling tool. Our design process ensures the firmness on these three angles: we assure the strict compliance based on norms (NOM-232 and NOM-182), we construct clear guidelines to a secure and efficient management, and we crate the arguments that maximize the business potential of your product.
Management of Import Permits
We manage efficiently the processes in view of COFEPRIS and SEMARNAT to import your products, either with commercial purposes, for quality tests, analysis from the laboratory or for research projects (as Biological Effectiveness Studies or Field Tests).
Advanced Scientific and Technical Support
Field Studies (Biological Effectiveness)
We apply a methodology of Project management to ensure the obtainment of the Technical Opinion of Biological Effectiveness. The process begins with the field study design strategically aligned to your objectives as reflected in your commercial label. Subsequently, we coordinate the execution with the network of recognized laboratories and researchers (in accordance to NOM-032 and NOM-077) and we lead administrative management in view of the Secretariat of Agriculture until the final opinion is obtained.
Authorization of Maximum Residue Limits (MRLs)
We execute the dietary risk assessment and the comparative analysis of use patterns, by delivering a complete technical report in accordance to NOM-082-SSA1-2017.
Computational Toxicology (QSAR)
We offer safety assessments without the need to perform animal testing, by using validated and acceptable models to COFEPRIS and other regulatory agencies. This service is a crucial tool to demonstrate the equivalence of chemical pesticides.
Building your Bridge towards Mexico.
For a detailed consultation, please contact us at
Office Phone: 55 56 05 24 67
Mobile Phone: 55 40 14 50 68