Contact

LRSS is owned by Linda Lebon, MsC, MBA

Linda has twenty years of experience in Regulatory Affairs & Drug Development. It includes experience in submission, preparation and contact with European Regulatory Authorities for Marketing Authorization Application (MAA) for Biological Products in Pharmaceutical companies.

Experience in Regulatory Strategy on Drug Development, from early stage up to approval, optimizing the claim granted. Scientific advice (SA), ODDA, Workshop lead, PIP, Pre-IND, EOP2, MAA, NDA/BLA preparation of documents and meeting attendance in various therapeutic areas including biotech products and with high focus in oncology. Experience in Regulatory Affairs with European Regulatory Authorities including EMA for MAA, Scientific advice, ODD, PIP and Regulatory Strategy in various therapeutic areas. People management, project team approach and financial responsibility which allow a full understanding of the company’s objectives and work align to their goals. Linda couples her scientific knowledge with hands-on Regulatory experience in

both Europe and the United States. Linda has a proven record of accomplishments in bringing drug candidates from discovery to IND/CTA phase, culminating with submissions of MAAs.

Among Linda’s assets are her international exposure and familiarity with the culture and pace of both large and small-to-medium size companies. Her insightful grasp of Drug Development and Regulatory matters is enhanced by her scientific understanding of the challenges with which pharmaceutical companies are confronted in their effort to bring a promising drug candidate from the preclinical stage to the market place.