Denisa Gologan

Miss Denisa Gologan is regulatory efficacy advisor for Exponent International, with over a decade of experience supporting the regulatory success of Plant Protection Products (PPPs), fertilisers and biostimulants across the EU27 and UK. Her expertise lies in designing and coordinating efficacy study plans, coordinating data gap analyses, and preparing high-quality Biological Assessment Dossiers (BADs) aligned with EU regulatory guidance.

She has deep knowledge of Regulation (EC) No 1107/2009, the central legal framework for placing PPPs on the EU market, and ensures that all efficacy data packages are fully compliant with its stringent standards. Denisa plays a critical role in advising clients on strategic trial design, regulatory submission planning, and data interpretation aligned with SANCO/10055/2013 Rev.4.

In addition to her PPP expertise, Denisa also supports regulatory compliance for fertilisers and biostimulants, with strong working knowledge of the Fertilising Products Regulation (EU) No 2019/1009. She has successfully led the preparation and submission of both PPP and biostimulant dossiers, contributing to product approvals across multiple jurisdictions.

Highly client-focused, Denisa routinely liaises with regulatory authorities and cross-functional teams to resolve scientific and regulatory queries. She brings extensive operational experience in trial management and compliance, having personally designed and reviewed thousands of efficacy studies covering a wide range of products — from herbicides and fungicides to seed treatments and biostimulants.

Her strategic mindset is complemented by hands on experience in R&D, project management, and regulatory operations, supported by tools such as Smartsheet, KeyedIn, Wrike and Veeva Registrations. Denisa also maintains multilingual fluency in English, Spanish and Romanian, adding value in cross border regulatory communication.