Regulatory and Compliance for Biotech

The regulatory, policy and standards landscape surrounding biotechnology and climate can be daunting and navigating them requires more than just knowledge; it requires a creative and strategic mindset. This is particularly true for innovations, given regulations are not tailored for them.

I truly believe in the transformative potential that biotech innovation holds to reshape the future, and my regulatory expertise is dedicated to guiding those who are willing to lead the change.

I can help you with my expertise to:

• Map regulations applicable to your innovation

• Desig the Regulatory strategy and path to market

• Ensure Regulatory compliance across product lifecycle

• Analyze data gaps and defining cost-effective safety data package

• Achieve product registration, including: crafting the dossier, performing the risk assessment  and submitting to authorities

• Plan and identify opportunities for geographical expansion

• Position, label and claims associated to your innovation

About myself

I'm a PhD and experienced regulatory professional in the biotech sector. I held regional and global regulatory leadership roles in both established multinational companies such as Monsanto, Bayer, BASF and Chr Hansen, and dynamic startups operating in the climate and sustainable agriculture sector. I bring vast experience in designing global regulatory strategies, bridging the gap between scientific innovation and commercial success, managing complex projects, securing regulatory approvals, and leading successful market launches across the globe.

My expertise within biosolutions spans mainly across Agriculture, Food and Feed, but also Biocides and new materials. Across these sectors I hold deep expertise in the risk assessment for contained use or environmental release of genetically-modified organism (GMOs) and products derived from new genomic techniques (NGTs).