Why timing, context, and message matter more than you think
For AgTech startups, engaging with regulators can feel intimidating—sometimes even risky. Get it wrong, and you may trigger costly requests or erode trust. Get it right, and you gain clarity, confidence, and valuable feedback that can shape your product’s success.
So when should you reach out? And just as importantly, what should you say (or avoid saying) when you do?
The Purpose of Early Engagement
Regulators aren’t just rule enforcers. In many jurisdictions, they’re open to pre-submission meetings or scientific consultations designed to support innovation and clarify expectations. When timed strategically, these conversations can:
- Confirm your product’s classification
- Align on intended use and claim language
- Reduce the likelihood of major data gaps later
- Build trust with reviewers ahead of submission
But for these benefits to materialize, preparation is key.
When to Initiate a Conversation
We recommend engaging regulators once your product concept is well-defined, your intended use is clear, and your early data strategy is in place—but before you begin generating final safety or efficacy studies.
This ensures you have something meaningful to discuss (like exposure modeling or risk hypotheses), while still leaving room to adapt your approach based on regulatory input.
In short: engage when your product is framed, not fixed.
What to Bring to the Table
Every regulatory meeting is an opportunity to demonstrate that your team is credible, prepared, and committed to safe, science-backed development. That means showing:
- A clear product definition and intended use
- Preliminary data or study plans
- An understanding of relevant policy or guidance documents
- Specific, well-structured questions that help regulators help you
What Not to Say
While transparency is important, avoid putting regulators in a position where they have to take a hard stance prematurely—or question the quality of your thinking. That includes:
- Overpromising product claims before data supports them
- Asking open-ended “what would you require?” questions
- Sharing undeveloped ideas with unclear regulatory relevance
- Comparing your product to others as a justification
These missteps can stall the conversation or even trigger regulatory skepticism.
Treat It Like a Strategy Meeting
Approaching a regulatory conversation like a pitch meeting or negotiation is a mistake. The goal isn’t to win approval—it’s to align expectations, reduce surprises, and show that your development plan is serious and scientifically grounded.
Our Approach
At Hjelle, we prepare clients for regulatory interactions by building clear briefing documents, scripting strategic talking points, and participating directly in pre-submission meetings. We know the questions to ask—and the ones to avoid.
Conclusion
Talking to regulators too early (or too casually) can create confusion. Too late, and you risk rework or rejection. The right time is when your product is defined, your science is structured, and your questions are sharp. With the right preparation, these conversations can be one of your most valuable development tools.
Thinking about your first regulatory interaction? We can help you get it right.
