About Us
Established in 2009, YDE Biomed Consulting is an independent consulting firm designed to help you negotiate the minefield of FDA regulatory compliance and give you a clear advantage.
YDE Biomed Consulting Core Values
Integrity: we build trust through responsible actions and honest relationship. We value confidentiality.
Service: we stand behind our top quality service and output to meet our customers’ needs and constraints.
Competency: we constantly learn to maintain high level of skills to bring to our customers.
Delivery: we are committed to deliver excellence and achieve all milestones until the final objective.
Partnership/team work: we believe in close collaboration every step of the way and aspire to operate as an extension of our customer’s internal team.
Adaptability: we keep an open mind by transforming our practices to maintain effectiveness in a changing environment
Why YDE Biomed Consulting?
Grounded for 30 years in California and interfacing directly with FDA, we also bring the benefits of our European background to foreign companies. With one foot on both sides of the Atlantic, we are well positioned to help overseas companies bring their innovative products to the large U.S. market. We offer services bilingual in English and French to facilitate the preparation of your submission.
Catherine Gloster, M.Sc., RAC - President
Catherine has nearly 30 years of experience in the medical industry. She brings her engineering background to guide product development to support successful clinical and regulatory submissions. Her background is key in writing and reviewing all the technical documentation that is required to secure a FDA approval. She also brings a rigorous, structured and well organized approach to submissions and data driven analytical skills.
Prior to starting her consulting business, Catherine held Senior Executive and management positions in various disciplines of corporate business: Vice-President of Quality, Regulatory and Product Development at Biosensors International, Vice President of Technology and Clinical Research at MediCor Development, Director of Manufacturing Technology and Support at Allergan and management positions in quality, validation and operations at Inamed Corporation.
Catherine holds a Masters of Science in bioengineering from Georgia Institute of Technology (Atlanta, GA) and another Masters in biomedical engineering and materials science from the University of Technology of Compiègne (France).
Additional resources: Catherine has developed long term and trustworthy professional relationships with a network of resources: those are highly qualified professionals who can support specialized activities.