Regulatory Strategy and Support is a new Regulatory Affairs services company led by Glòria Martin Rauret, with and Organic Chemistry background and with over 25 years’ experience in the field of Regulatory Affairs in the pharmaceutical sector.
Glòria began her career in the Regulatory Affairs world in the active pharmaceutical ingredients industry, writing and compiling Drug Master Files for submission to the FDA.
The early years of her career focused on CMC Regulatory Affairs but soon extended to the development of new drugs, including clinical and non-clinical regulatory topics and focusing on Regulatory Intelligence and Regulatory Strategy tasks.
She has actively participated in several international development projects in defining regulatory strategies, preparing Scientific Advice, pre-IND and End of Phase II meetings, obtaining authorisations for conducting clinical studies in four continents and leading the most advanced regulatory stages of development.
The expertise gained in the development of new drug products, frequently liasing with the most relevant international regulatory agencies and especially FDA, constitute a sound basis to start a new project offering to accompany your project and your company along the regulatory pathway to success.