Historically, agtech regulatory expertise has been siloed in only the world's largest companies.
We've changed that.
Why HCG
Global Regulatory Experts
Simply put, no other entity outside the "Big Four" multinationals can compete with our cumulative regulatory and product development expertise in the AgTech sector. From counter-season field trial capabitilies to in situ relationships with regulators, from D.C. to Brussels, Beijing to Brussels, from Tokyo to Buenos Aires, our flexible teams deliver solutions around your existing assets.
Concept Validators
Wise AgTech investors look beyond narratives and assess whether an exciting discovery has a path to becoming a product. HCG is regularly utilized by both innovators and investors - from venture capital to private equity to investment bankers - to validate, deepen, and drive product concepts and design.
Integrated, Flexible Solution Providers
HCG can manage your entire regulatory workstream, unshackling your organization's bandwidth to focus on other critical issues. We are not just expert technicians - our people have led groups, teams and entire departments at the Big Four, executing simultaneously on multiple products and submissions. Our distributed network fits around your needs.
Leaders
Jerry Hjelle, Ph.D.
Lead Consultant
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HCG is lead by Lead Consultant Dr. Jerry Hjelle, who served as Vice President of Global Regulatory and Affairs at the Monsanto Company for nearly two decades.
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Shawna Lemke, Ph.D.
Food Safety Lead
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Shawna Lemke is our Food Safety Lead, having previously served as Vice President of Public Affairs at the Monsanto Company.
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Ron Lirette, Ph.D.
Regulatory Science Lead
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Dr. Ron Lirette is our Regulatory Science Lead, having previously services as Director of Regulatory Science at the Monsanto Company.
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Stephen Waters, Ph.D.
Regulatory Affairs Lead
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Dr. Stephen Waters is our Regulatory Affairs Lead, having previously served as Director of International Regulatory Affairs at the Monsanto Company.
What We Offer
Review of Regulatory Strategy and Data
Our engagements begin with a review of the client's existing regulatory strategy and data, checking for data gaps and validating client assumptions. Our team conducts a Deep Data Dive and Pre-Regulatory Assessments to determine future activities.
Pipeline Support
Where pipeline support is needed, HCG works through a network of contract research organizations to help manage all phases of product development, whether in-house for the client or through collaborators; past work includes:
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Product development method selection
Protein/RNA selection for modification
Vector/design guides
Pipeline process optimization
Quality systems for product integrity and Stewardship
Analytical toolkit development
Event characterization for pipeline advancement
Selection of events for commercialization
Pre-Submission Reg Affairs and Science Policy
Our regulatory affairs experts hold pre-submission meetings with their regulatory counterparts to properly frame intended use and align on required data to minimize the potential for regulatory review delay once the submission is made. For more cutting-edge products where regulatory policy is still in flux, Dr. Hjelle and other senior HCG members engage in Scientific Policy outreach to advocate for science-based regulations.
Dossier Submission, Q&A and Registration
Having now framed the concept and intended uses in pre-meetings with regulators, our regulatory affairs experts construct and deliver the product safety dossier, proactively addressing any concerns or requests for additional data. For information on recent successes, see below.
Global Registrations
Expand ROI with registrations in key import and cultivation countries, including:
Argentina
Australia
Brazil
Canada
Chile
China
European Union
India
Japan
New Zealand
Paraguay
South Korea
Taiwan
United States
Product Expertise
Our consultants have played key product development and regulatory roles at the world's largest agricultural biotechnology companies, with a history of success across a wide range of product types. ​Our leadership won global approvals for a variety of foundational AgTech products, including RoundUp Ready Corn, Soybeas, Cotton, Canola and Sugarbeets, Bollgard and Bollgard II (cotton), VipTerra Corn and Intacta Soybeans, amongst many others.
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In the plant
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Transgenic, i.e., "GMO" plants​
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Insect-protected​
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Herbicide-tolerant​
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Quality traits​
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Remote-sensing​
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Protein and RNAi based​
mechanisms of action​
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Gene-edited plants
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On the plant
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Agricultural chemistries​
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Soil health​
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Microbials​
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Biologicals and biochemicals
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Added to food
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GM microorganism-derived ingredients​