Five Considerations Preceding Regulatory and Commercialization

Like most new concepts, technology starts at the beginning of a product development process. Hungry and talented technologists often cannot cover all the product development bases when it comes to getting their new concepts to market. At AgriThority®, we use a disciplined, proven Prescriptive Response™ development process to help fill gaps for innovators and research-driven companies.  

As we lay out the activities specifically related to global registration and commercialization, consider five critical elements:  

        1. Consider the components of your product and their supply chain
          Your dossier will include information on the components of your product. Did you fully consider the cost models and the long-term viability of your supply chain? You want to be as flexible and cost-effective as possible. To go back and amend your dossier to add additional raw material sources can add many years to your commercial launch. 
        2. Consider your manufacturing process
          Government agencies are like you: They do not want to make judgements on a moving target. Part of your dossier will include information on how your product is made, and the regulatory agencies will hold you to your manufacturing process even if it results in a process too long to conduct or too expensive to run.  
        3. Consider your logistics
          Cost modeling, timeliness of modes of transportation and fighting with others for your tolling manufacturer’s resources, plus tariffs–all these elements feed into the decisions on where you manufacture, repackage and distribute your product. What the regulatory agencies see are all the places you intend to conduct commercial activity. Many times, those involved need to be registered players as well. Again, you want to be as flexible, timely and cost-effective as possible.  
        4. Consider how well your product will hold up in storage and transport
          For example, if you made a product that met specifications in Europe, and now you want to bring that product to the U.S., questions arise:  Will it survive the ride on the boat, the winter in the distributor’s warehouse in North Dakota and the summer in the applicator’s shed? The “snake oil” salesmen over the years have driven authorities into enforcing whether the jug of product is what your label says it is. This can become a difficult proposition, particularly with the new bio-based technologies that are driving innovations today.  
        5. Consider safety to workers and the environment
          You have a competitive edge if you not only reduce rates of the conventional chemistry technologies that are applied onto crops, but also lower risks and hazards due to worker exposure and environmental release. Today, there is increased scrutiny about soil health, risk to endangered species and food residue exposure. The more the safety factors can be characterized in your product, the more favorably your technologies can be seen.  

For more information on ensuring a seamless regulatory process, refer to the 10 Regulatory Planning Steps to Avoid Disappointment.

When your agricultural technology is moving from Research into Development or into new markets, AgriThority has the technical expertise to supplement or expand your internal capabilities for business, market or product development.  

With internationally recognized leaders connected to more than 300 local specialists in a worldwide network, we bring deep experience testing more than 170 new technologies across 1500+ field trial locations for 180+ multi-national, mid-size and start-up companies.  

Wherever you want to explore, we are your native guides.