CRO Challenges in Latin America
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By Lauren Milligan
Latin America has long been recognized as a key market for agrochemical and biological research and development, offering significant opportunities for growth. However, as contract research organizations (CROs) work to conduct field trials across the region, companies face varying regulatory requirements, evolving data needs, and the push for sustainability.
Industry experts Adriana Puralewski, Business Development Manager North America for Staphyt, Roberto Sardinha, International Sales Manager for Mérieux NutriSciences, and Jorgelina Lezaun, CEO and Founder for AgriConsult LATAM provide insights into the challenges and opportunities for CROs navigating the Latin American agricultural sector.
Regulatory Complexities and Approval Delays
One of the most persistent challenges for CROs in Latin America is the fragmented regulatory environment. While countries like Brazil, Mexico, and Argentina share some commonalities in their regulatory frameworks for plant protection products, each nation’s approval process varies significantly, requiring companies to adapt to different documentation, technical, and procedural challenges.
Jorgelina Lezaun, CEO and Founder, AgriConsult LATAM
Lezaun highlights three key regulatory challenges for CROs in the region. First, the translation of country-specific documentation requirements is essential to avoid delays. Second, companies need to be aware of differing technical evaluation criteria that may require extra trials, increasing costs and timelines. Third, each country’s regulatory agencies have varying review processes, and policy shifts can disrupt operations across technical and administrative areas.
Beyond these challenges, Lezaun also emphasizes the role of industry associations and chambers in working collaboratively to improve regulatory frameworks. “There is a strong commitment from associations and industry groups to align efforts in enhancing regulations that add value to all players in the value chain,” she says.
One notable initiative is the Interactive Regulatory Map launched by CropLife Latin America, which provides real-time updates and insights into key regulatory developments across central countries. This tool helps stakeholders track and navigate evolving compliance requirements more efficiently (CropLife Latin America).
Brazil is widely known for its rigorous regulatory system, which is notoriously slow. “Brazil takes the longest time to approve registrations, followed by Mexico,” Puralewski says. However, recent legislative changes, such as Law nº 14.785/23, are expected to streamline the registration process and shorten approval timelines.
Sardinha says it’s not only Brazil that has a challenging regulation process.
Roberto Sardinha, International Sales Manager, Mérieux NutriSciences
While Brazil’s regulations are robust, each country in the region has its own regulatory landscape,” says Sardinha. “For example, Mexico often requires additional data, leading to prolonged approvals, while Argentina has recently taken steps to simplify its process, allowing companies to bypass certain requirements if they have prior approvals from recognized regulatory agencies.”
There are efforts being made to speed up approval timelines in the Latin American region. Lezaun says Argentina’s SENASA has streamlined processes to reduce regulatory redundancies, while Brazil is adopting digital systems for better data management and centralized agrochemical registration.
Despite some progress, regulatory harmonization across Latin America remains a long-term challenge.
Evolving Field Trial and Efficacy Data Needs
As demand for biological products increases, field trial and efficacy data requirements are evolving. Regulations now require more localized data to reflect diverse agro-climatic conditions, pests, and disease pressures.
Adriana Puralewski, Business Development Manager North America, Staphyt
“Field trials must be conducted in representative areas, with careful attention to timing to meet regulatory windows and ensure compliance with international standards,” Puralewski says.
Key trends in field trial requirements for biological products include stricter environmental impact assessments on drift, non-target species, and IPM compatibility. Evaluation periods are extending to monitor post-application effects and residues. There is also a growing focus on biological product stability, assessing persistence in field conditions and compatibility with synthetic inputs, says Lezaun.
Three Key Research Priorities for Brazil and Argentina
Research priorities in Brazil and Argentina are shaped by local grower needs, climate conditions, and evolving regulations.
Lezuan says three key research priorities for CROs in both markets include:
| Resistance: “Testing product efficacy against resistant pests and weeds, particularly in soybean and corn production.” |
| Climate change: Another priority is evaluating product performance under extreme environmental conditions. “Understanding how products perform in droughts, extreme heat, or high-humidity conditions is critical for long-term adoption.” |
| Regenerative Agriculture: Additionally, the rise of regenerative agriculture and no-till practices demands rigorous testing. “In Argentina, no-till farming dominates, so products must be tested for soil penetration, interaction with microbiota, and compatibility with cover crops.” |
Ag Tech and Formulation
As Latin American countries embrace technology-driven agricultural market, with a growing focus on sustainability, precision farming, and digital traceability, key R&D working in tandem with ag tech will be drivers moving the industry forward.
Digital agriculture and IoT sensors are enhancing real-time monitoring and predictive analytics, while regenerative practices are fueling demand for low-impact biological products, says Lezaun. Additionally, microencapsulated and controlled-release formulations are improving product stability and efficiency across varying climates.
“Global companies must understand Latin America’s market segmentation—smallholder farmers have different needs than export-driven agribusinesses,” says Lezuan. “The industry must adapt its solutions accordingly.”
The regulatory landscape for CROs in Latin America is complex but also presents significant opportunities for those who can navigate evolving regulations, research priorities, and sustainability trends.
As Puralewski, Sardinha, and Lezuan emphasize, strategic planning, regulatory expertise, and local adaptation will be key to success for CROs and global agrochemical companies operating in the region. •
tong2530 – Adobe.stock.com
Jorgelina Lezaun: Agriconsult LATAM
Roberto Sardinha: Mérieux NutriSciences
Adriana Puralewski: Staphyt
