What Exactly Is the Product?
Regulatory strategy starts with a clear product definition.
When we engage with clients developing a new agricultural technology, one of the first questions they often ask is:
“What is the regulatory pathway?”
It is an important question. But it may not be the first one we need to answer.
Before we can understand the pathway, we need to understand what the product is in their mind.
A technology platform can generate the components of a product, such as RNA sequences, peptides, microbial strains, formulations, or delivery systems. But a platform is not yet a regulatory product.
Regulatory decisions ultimately need something more specific:
What is the active ingredient?
How is it produced?
What else is present in the final formulation?
Which crop and target will it be used for?
How will it be applied?
At what dose and frequency?
What benefit will the product claim?
If these elements are still changing, the regulatory pathway may also change.
Small Changes Can Have Large Consequences
Product decisions are connected.
A change in formulation may affect product stability, environmental exposure, analytical methods, manufacturing controls, or safety testing.
A change from foliar application to seed treatment may create a different exposure profile and require different evidence.
A new crop, target, dose, or application frequency may affect efficacy studies, residue questions, environmental assessments, and the intended label.
Even an improvement can create consequences.
A new formulation may produce better field performance but make earlier studies less representative of the final product.
A broader claim may increase market potential while also expanding the evidence needed to support it.
This does not mean a product must be completely fixed at the beginning of development. Early programs naturally evolve.
But teams should maintain a clear working definition of the product and understand which assumptions remain open.
Define the Product Before Defining the Pathway
A useful early exercise is to write a one-page regulatory product concept.
It does not need to be a final regulatory document, but should simply describe the product as the team currently understands it:
Active ingredient and biological function
Manufacturing process
Formulation
Target pest or disease
Crop and geography
Application method
Dose and frequency
Intended claim
Expected customer use
This simple document can reveal important gaps during product development due to the following reasons:
The scientific team may be developing several formulations.
The commercial team may be imagining a broader use pattern.
The regulatory team may be evaluating a pathway based on an earlier product concept.
Manufacturing may be optimizing a process that changes the product’s impurity profile.
Regulatory Strategy Is a Cross-Functional Discipline
Early regulatory thinking helps connect these different perspectives.
It can show which product changes are relatively easy to absorb and which could affect the wider development program.
It can also help teams decide when flexibility creates value and when continued change begins to create unnecessary cost, delay, or rework.
Three questions are especially useful:
Which product elements are already defined?
Which elements are still expected to change?
Which change would have the greatest effect on the evidence package or regulatory pathway?
These questions turn regulatory planning into a development tool.
The goal is not to predict every regulatory requirement from the beginning. Nor is it to prevent scientists from improving the product.
The goal is to make product evolution visible, deliberate, and connected to its consequences.
Start Earlier Than the Dossier
Regulatory strategy should not begin when the team is ready to assemble a submission.
By then, many of the most important regulatory decisions may already have been made indirectly through choices about the active ingredient, manufacturinåg process, formulation, claim, and use pattern.
The earlier question is therefore not only:
“What pathway applies to our technology?”
It is: “What product are we actually developing åand what evidence will that product require?”
A clear product definition does not remove uncertainty.
But it gives scientific, regulatory, manufacturing, and commercial teams a common starting point for managing it.
At what stage should an emerging biological product receive its first formal regulatory product definition?
