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Professional Toxicology Services
"TGen TD2 provides a broad range of regulatory expertise and services with integrated project management to ensure that client programs run seamlessly into clinical development..."
TGen Drug Development (TD2)
Stephen Gately Ph.D, President & Chief Scientific Officer
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Regulatory Affairs

Raymond C. Lamy, MS
President and Regulatory Affairs Expert
ARCIEL, LLC

Mr. Lamy has over twenty-five years of combined pharmaceutical/biotech industry experience in Regulatory Affairs, Clinical Statistical Programming, and Nonclinical Research, focusing on the development and marketing registration of prescription drug/biotechnology products in several therapeutic areas (i.e., oncology, CNS, pain management, anti-infective). Additional experience with nutritional supplements (“nutriceuticals”), 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. Submitted and/or managed successful clinical trial applications and new drug applications worldwide. Particularly experienced with the FDA’s CDER, DEA, Orphan Products, and International Affairs divisions; 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.

Mr. Lamy has assisted with regulatory strategy and issue resolution, competitive product intelligence research, scientific/medical/label writing, SOP development, and determining the viability and commercial potential of products for either acquisition and/or in-house development.

  • Successful electronic IND and NDA submissions, compliant with FDA regulations, including eCTDs

  • Developed various systems for expediting Regulatory Affairs work (i.e. document standards and templates, electronic regulatory file management and tracking system)

  • Developed and managed successful Regulatory Affairs groups at start-up, small, and medium sized companies

  • Participated in bringing a privately held company to an initial public offering (IPO)

  • Dedicated to Quality, Efficiency, and Team Work

  • Master’s degree in Computer Science and Bachelor’s degree in Life Sciences


Click here for a copy of Raymond Lamy's curriculum vitae