By Dr. Jerry Hjelle
In today’s competitive agtech environment, groundbreaking science alone is no longer enough to secure capital or accelerate value creation. A robust regulatory strategy has become essential—not only for attracting serious investment, but also for ensuring successful exits.
At Hjelle Consulting Group (HCG), we’ve guided numerous companies through the regulatory maze in key markets such as Brazil, China, the U.S., and the EU. Major companies and investors now prioritize funding startups with clear regulatory pathways and defined approval timelines—especially in today’s more cautious funding climate.
The Misconception: “We’ll Handle That Later”
Founders often focus early efforts on innovation, intellectual property, and proof-of-concept validation. But as R&D transitions into product development, deferring regulatory planning becomes a critical oversight. Regulatory processes are often the longest and most complex path to market.
A startup without a regulatory roadmap is viewed as high-risk by investors—not because they expect every study to be complete, but because catching up later can be a deal-breaker. Based on conversations we had with investors at the World Agri-Tech conference in San Francisco earlier this month, this remains a core belief.
At Monsanto, regulatory strategies were embedded throughout the product lifecycle—from selection to testing to regulatory science to global approvals—ensuring alignment and efficiency from day one in a virtuous feed-back loop.
Investor Expectations Have Evolved
Veteran agtech investors now understand approval timelines and key regulatory bodies like CTNBio, EFSA, and MARA. Many have seen startups fail after trying to retrofit data into dossiers that ultimately get rejected.
Given that regulatory can often be the critical path from product selection to launch, founders must proactively manage regulatory planning and budgeting. In today’s market, there’s little appetite for “magical thinking” when it comes to regulatory strategy.
Your regulatory plan is no longer optional—it’s a gating factor for investment and exit success.
Steps Founders Must Take
Even with limited capital, you can begin building your regulatory foundation early:
- Map the Regulatory Landscape: Identify your key markets and their dossier requirements.
- Design Research with Purpose: Align your data package with regulatory standards from the start.
- Engage Regulatory Expertise Early: A seasoned consultant helps you make informed decisions, avoid costly missteps, and boost investor confidence.
- Make It Part of Your Investment Narrative: Demonstrate how your science leads to market access and scale.
Regulatory Strategy = Competitive Advantage
You’re not just developing a product—you’re developing an asset.
A strong regulatory plan and budget are essential for future fundraising and successful commercialization. At HCG, we see regulatory readiness as a strategic enabler—transforming promising technologies into approved, scalable, investable assets.
A regulatory plan isn’t an add-on—it’s foundational. It signals to investors, partners, and acquirers that you’re building something to last.
— Dr. Jerry Hjelle Lead Consultant, Hjelle Consulting Group (HCG)
