About Us
Rautaki Solutions is an Australian consultancy specialising in the regulatory approval, biosafety and commercialisation of biotechnology products across food and agriculture. We combine scientific depth with a practical understanding of how regulators think and how products actually reach the market.
We start with strategy. Before anything is drafted, we work out the pathway, where the risks sit, and what evidence will carry the decision. We are candid about what a project needs. If a pathway is difficult, we say so early.
Sectors
We maintain a focused approach, working in areas where we hold extensive expertise across crops, technologies and regulatory frameworks
Rautaki Solutions provides end-to-end expertise in navigating the complex regulatory, biosafety, and commercial landscapes for biotechnological products. Engagements range from a single submission to an ongoing partnership across a product's whole life.
What we do
Regulatory Affairs
Navigating complex regulatory landscapes requires strategic foresight and deep jurisdictional expertise. We provide comprehensive, end-to-end regulatory strategies for genetically modified organisms (GMOs) and new breeding technologies (NBTs). From initial pathway development to final approval, we manage complex submissions and act as the primary liaison with key statutory bodies, including the Office of the Gene Technology Regulator (OGTR), Food Standards Australia New Zealand (FSANZ), and the Australian Pesticides and Veterinary Medicines Authority (APVMA). Our focus is on delivering secure, predictable regulatory outcomes for agricultural and biotechnological innovations.
Scientific and Technical Writing
High-quality, robust data presentation is the cornerstone of regulatory success. We specialise in translating complex molecular biology, bioinformatics, and field trial data into rigorous, compliance-ready documentation. Our capabilities encompass drafting detailed environmental risk assessments, dietary exposure reports, and comprehensive protein allergenicity and toxicity evaluations. By integrating advanced statistical analysis and data modeling directly into our technical reports, we ensure your scientific evidence is communicated with the precision and clarity that regulatory evaluators demand.
Commercialisation and Stewardship
We transform agricultural innovations into commercial realities. By pairing rigorous product stewardship with targeted commercialisation frameworks, we guide technologies from early-stage proof of concept through to global market access. We actively manage technology compliance, and strategic industry partnerships to ensure your product is positioned securely and successfully in the market.
Physical Containment
Maintaining strict biosafety standards is non-negotiable in biotechnology research and development. We provide rigorous oversight and compliance management for certified physical containment facilities and external field trial sites. We ensure that all operational protocols, facility certifications, and biological material handling procedures strictly adhere to statutory guidelines, actively mitigating risk and safeguarding the integrity of your research programs.
Leadership
Dr Carl Ramage GAICD Managing Director
Carl has spent more than 25 years supporting the development of novel agricultural biotechnology products in Australia across the supply chain.
​
He translates complex biosafety and regulatory requirements into practical, auditable pathways to market. His experience spans more than 25 intentional release licences under Australia’s Gene Technology Act and Regulations, including commercial and limited and controlled release programs in broadacre crops, yeast fermentation and biomedical therapeutics. His work covers licence application preparation, FSANZ dossier development for GM food crops and precision fermentation-derived food proteins, OGTR compliance management, contingency planning, trial site logistics, and regulatory pathways for facilities producing food proteins and industrial chemicals.
​
Carl also advises on positioning gene-editing technologies against evolving Australian regulatory definitions, helping industry stakeholders navigate the path from R&D through to commercial release. He is the sole Excellence Through Stewardship and Plant Breeding Innovation Management Program auditor in the South Pacific, supporting product stewardship and quality management across the grain technology life cycle.
​
He completed his PhD at the University of Queensland and holds a Master of Science with Honours from the University of Canterbury, New Zealand.