Raymond Lamy, MS

Regulatory Affairs (Senior Consultant)

Raymond Lamy has over twenty-five years of combined pharmaceutical/biotech industry experience in Regulatory Affairs, Clinical Statistical Programming, and Nonclinical Research, focused on the development and marketing registration of prescription drug/biotechnology products in several therapeutic areas (i.e., oncology, CNS, pain management, anti-infective).

He has additional experience with nutritional supplements, OTC monograph products (antifungals and digestive aids), biologics (blood plasma derivatives, human growth hormone), and medical devices (drug delivery).

Mr. Lamy has extensive knowledge of US FDA regulatory requirements, having submitted and/or managed successful clinical trial applications and new drug applications worldwide. He is particularly experienced with the FDA’s CDER (several reviewing Divisions), DEA, Office of Orphan Products Development, and Office of International Affairs; with additional experience with California’s DHS (manufacturing facility and clinical laboratory licenses), CLIA registrations, Health Canada’s TPD, the EMEA, and some Intercontinental/Pacific Rim country health authorities.