End-to-End Regulatory Support That Goes Beyond Commercialization

As a concept moves through scoping toward early stages of product development, governmental directives or restrictions must be defined for each target market to ensure registration and compliance. As the product evolves so should the regulatory process. There are many regulations and country and state permit requirements throughout the process of getting a new product to market. One aspect that is sometimes overlooked or is easily dismissed is the actual logistics of moving products – especially novel ones. AgriThority® provides end-to-end regulatory support, even beyond commercialization.

Are you planning early for biological regulatory barriers?

When moving agricultural innovation across borders, the regulatory strategy and pathways must evolve early in the planning process. Import, movement, and release of many products require permits that take time to obtain. It is important to explore permit needs well in advance of planned shipments.

The AgriThority® biological and logistics experts define global requirements for dossier preparation, submission, permitting, logistics, importation, and regulatory compliance. Skipping or overlooking proper regulatory procedures — even unintentionally — poses significant risks. Shipments arriving in the U.S. undergo random inspections, and those found without appropriate permits can result in substantial fines, shipment delays, loss of product, and potential revocation of importer licenses. Ensuring regulatory compliance from the outset helps companies avoid these costly and disruptive outcomes.

AgriThority® provides comprehensive, end-to-end regulatory support, which minimizes risk across all product development stages. For example, the team recently managed the export of an experimental product to Brazil . After the product arrived at our Kansas City facility, we repackaged, relabeled, and coordinated shipment to the contract research organization (CRO) in Brazil. This enabled a timely initiation of the field trials, which were also managed by AgriThority. This is how AgriThority can integrate regulatory compliance, logistics coordination, and trail oversight into one streamlined solution.

Defining Regulatory strategy and pathways

Clearly defining desired product claims early in the development process helps define the regulatory strategy and pathways within targeted geographies. Identifying the potential claims, formulation details and intended market direction directly influences the data needs for registration of a new technology.

Effective execution requires knowledgeable and well-connected regulatory experts within regions or countries around the world. The variables and ever-changing policies are complex and unique to each regulatory body. Our network is engaged with the policy makers and supervisory departments on a regular basis to ensure timely and relevant regulatory counsel. This close connection allows us to advocate for client interests, engage in pre-submission meetings, and support ongoing regulatory compliance. With a regulatory pathway clearly defined, the next critical step is managing the complexities of global permitting and logistics.

Navigating Permitting and Global Logistics

Moving technology across borders legally has many complexities regulated by different authorities around the world. Navigating the checkpoints, notifications and documentation is a specialty service that includes compliance within evolving requirements.

Additionally, the process for regulated trials for genetically modified organisms (GMOs) requires the creation of detailed Standard Operating Procedures (SOPs), Chain of Custody documentation, and compliance checklists. AgriThority® expertly prepares and reviews these critical documents, which are key components of a field release for regulated trials, and ensures readiness for USDA inspections.

Our logistics team provides comprehensive fulfillment services capable of handling warehousing, inventory management, inventory (SKU) management and label tracking, repackaging and reshipping according to regulatory standards. At our warehouse facility in Kansas City, we securely store products for both experimental trials and commercial use. Being centrally located, we’re able to streamline shipping logistics to minimize shipping costs with the flexibility of rail and truck transport. Effectively navigating permitting and logistics enables the development of data needed for preparing the dossier and regulatory submission.

Streamlining Dossier Preparation and Submission

The many details and steps through to final product registration approval require constant scrutiny and tracking for each governing body. The AgriThority team’s regulatory expertise spans every step of this process, from initial literature reviews, risk assessments, and data gap analyses, to designing and managing registration trials or required studies. Our monitoring and validation of data is the first step toward detailed dossier preparation and submission of accurate materials. The final steps include supporting the final product label creation, tracking, or defending registration submissions for approval and freedom to operate.

AgriThority® carefully compiles and validates data, prepares submission packages tailored to local requirements, and proactively tracks dossiers through every step of the review process including defense of the submission by responding to regulator feedback in a timely manner.

Post Registration Compliance

Maintaining regulatory compliance doesn’t end with product registration approval. AgriThority® can track and manage ongoing compliance requirements, including annual EPA maintenance fees, state-level tonnage and mill assessment fees, and product renewals across all states. Our comprehensive approach ensures your products remain compliant while at the same time reducing the administrative burden and risk associated with missed deadlines.