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Raymond established Arciel, LLC in after several years of industry experience at pharmaceutical, biotech and international consulting companies. Arciel provides expert services in US regulatory operations including regulatory submissions life-cycle management, e-publishing and e-transmission, as well as consulting for FDA interactions including liaison with FDA on behalf of clients and regulation interpretation and strategic planning.
She provides word processing and e-publishing support for compliant eCTD submissions as well as e-transmission through ESG. She also maintains regulatory files and clinical trial documents e-dataroom and is experienced with processing submissions to the IRB.
In addition, she provides QC of eCTD-submissions and can assist with template style guides to ensure consistency within and across regulatory documentation. She helps clients tell their drug-development story from Phase 1 to market access and beyond.
Her medical writing services include translating non-clinical study results and clinical trial results into regulatory documents, peer-reviewed journal publications, and meeting presentations for professional audiences. Adkins, BS, BA Clinical Operations Consultant Rodney Adkins With over 25 years in the pharmaceutical research industry, Rod has an in-depth understanding of the Site, CRO and Sponsor sides of the business and is available to consult on a variety of clinical operations topics including site monitoring and management, vendor management, CRA resourcing and patient recruitment from study start up through closeout and archival.
Hobbies include golf and hockey and he is actively involved in youth mentoring programs. Paracelsus commenced conducting business as a corporate entity in January Knowledge of GLP regulations.
Biomedical areas of experience include diabetes, autoimmune diseases, inflammation, infectious diseases, pain management and cancer. Excellent written and oral communication skills.
Mark has worked in drug development for over 25 years and has broad-based experience with technical operations concerning development of drugs, biologics, and combination products.
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The Process of New Drug Discovery and Development, Second Edition presents a practical methodology and up-to-date scientific information for maximizing the.