Raymond C. Lamy, MS
US FDA Regulatory Expert
Raymond is President of Arciel, LLC and brings 30+ years of pharmaceutical industry experience to best support Arciel's clients’ drug development and regulatory submissions. He established Arciel, LLC in 2008 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.
Regulatory Documentation Expert
Cina has 15+ years of experience preparing documents (paper and electronic) for submission to US and international regulatory health authorities. She is an expert in MS Word (.doc), Adobe (.pdf), and DocuBridge One (.xml) software and 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.
Regulatory Documentation Specialist
Nico is proficient in MS Word (.doc) and Adobe (.pdf) software and provides word processing, e-publishing and QC support to ensure that documents are eCTD-ready for regulatory submissions.
Regulatory Documentation Specialist
Formosa Consulting, LLC
Formosa Consulting, LLC has 14+ years of experience in Regulatory Operations supporting submissions with US and international regulatory health authorities. As Owner-Manager, Sam provides publishing support and is proficient in Word and Adobe PDF to ensure that documents are eCTD-ready for regulatory submissions. In addition, he provides QC of eCTD-submissions and can assist with template style guides to ensure consistency within and across regulatory documentation.
Michelle Currie is a regulatory medical writer with more than 25 years of clinical research experience. She has been a major contributor to multiple successful initial Investigational New Drug Applications (INDs) and New Drug Applications (NDAs)/Biologics License Applications (BLAs). She has authored clinical study protocols and clinical study reports (CSRs) for all phases of clinical development. Michelle also has authored summary sections of regulatory licensing applications for pharmaceutical, biotechnology, and device products, in a wide spectrum of therapeutic areas.
Rodney L. Adkins, BS, BA
Clinical Operations Consultant
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. His therapeutic experience includes oncology, CNS, infectious disease and Schedule II-IV controlled substances.
Justin C. Lamy
Regulatory Affairs Intern
Justin obtained his Bachelor of Science from University of Connecticut in 2019 with a double major in pharmaceutical science/biology and communications, and a minor in psychology. He is pursuing a graduate program in Regulatory Affairs for Drugs, Biologics, and Medical Devices (concentration in Operational Regulatory Affairs) at Northeastern University in Boston, as well as additional interning opportunities at pharmaceutical companies.
Timothy C. Johnson
Regulatory Affairs Intern
Timothy obtained his Bachelor of Science from Marist College in 2017 with a major in Biomedical Science and a double minor in Chemistry and Psychology. He is currently gaining experience in the Regulatory Affairs field working at the Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center as the Regulatory Coordinator for all NCTN sponsored trials. In addition, Timothy is currently working towards his Master of Science and Health Sciences (MSHS) in Regulatory Affairs from George Washington University.
Grace M. Furman, PhD, DABT
Nonclinical Toxicology Expert
As CEO/President of Paracelsus, Inc., Grace provides professional toxicology services to the pharmaceutical industry as an independent consultant. She made the decision to become independent in mid 2006, at which time she was Senior Director of Regulatory Safety Assessment in Pfizer’s Drug Safety Research and Development department. Paracelsus commenced conducting business as a corporate entity in January 2007. Grace’s area of professional expertise relates to regulatory toxicology as applied to development of novel small molecule therapeutics.
Fred R. Kohn, PhD
Nonclinical Pharm/PK Expert
Fred has 25+ years of experience in the biotechnology and pharmaceutical industry designing and directing preclinical programs for product development (small molecules, proteins, peptides, monoclonal antibodies, drug delivery systems, cell-based therapies). Additional experience includes writing of US and international regulatory documents and interaction with regulatory agencies, research collaborations with academic laboratories, analytical methods development and setup of QA/QC/documentation systems, clinical trial design, monitoring of preclinical and analytical studies at contract facilities, and project management. 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 A. Staples, PhD
Cusp PharmaTech Consulting LLC (CUSP) was founded in 2007 and is based in Cambridge, MA. 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. The CUSP name and logo reference the radical transformation of the pharmaceutical industry due to the advent of biotechnology. CUSP enables the efficient translation of a promising drug from the discovery laboratory to the marketplace.
European Regulatory Affairs Expert
Niel is Managing Director at Sirius Regulatory Consulting, a progressive Regulatory Affairs and Drug Development Consultancy supporting the global pharmaceutical industry to achieve product development and regulatory approval in Europe.
ProPharma Services Corp
Nonclinical Pharm/PK Experts
ProPharma Services supports and partners with small to mid-sized biotechnology and pharmaceutical companies. Our expertise can assist in preclinical as well as clinical stages of drug development. We have broad experience in both small and large molecule drugs.
Brad Fox, BSME, MSML
FDA Regulatory Expert, Medical Devices
Brad has over 30 years of experience in the development, testing and Regulatory process with medical devices. His background includes multiple small business start-ups; completing strategic technology planning and evaluations as well as over 20+ years of direct FDA and CE process. Brad works as a liaison between the client and the FDA and has expertise in the preparation of medical device submissions including Request for Designations, Q-submissions, pre-IDE, IDE and De Novo. He also has special expertise in Combination Products, Companion Diagnostics and 3D Printing of medical devices.
Christine M.N. Smith, Ph.D.
Pharmaceutical Development (CMC) Expert
Christine provides professional expertise on CMC from the pre-clinical stage through commercialization. She has had hands-on experience in the areas of API, formulation, process, analytical methods, regulatory strategy, quality, and technical writing, working with peptides, small-molecules, parenterals, orals, non-conventional formulations, and drug-device combination products. Prior to consulting, Christine served as Executive Director, Product Development at Amylin Pharmaceuticals where she led the CMC department.
Clinical Development and Regulatory Affairs
Susan Jerian, MD and David Essayan, MD are co-principal consultants at ONCORD, Inc., a consulting firm providing clinical development and regulatory affairs expertise. They have worked with numerous pharmaceutical and biotechnology companies and academic researchers in North America, Europe, Australia and Asia. They specialize in challenging and complex development programs. Susan and David have a proven track record of bringing products through the development process, including pre-IND, IND and NDA/BLA/MAA approval.
Forsythe and Bear, LLC
Forsythe and Bear, LLC provides statistical consulting for the BioPharma Industry specializing in the design, analysis, and interpretation of clinical trials. Both Dr. Forsythe and Ms. Bear bring numerous years of clinical development experience including early, late phase, and post-marketing development.
Jeffrey L. Clarkson, JD, LLM
Jeff is a corporate transactional attorney with 30+ years of experience working for large and small law firms, Fortune 500 companies and the Federal Government.
Web Design & IT Services
Aaron founded Sigilware, LLC to help small businesses create a modern web presence. He's worked as a software developer for more than 20 years focusing on clean, engaging web sites.
Kevin B. Rotenberry, CPA
Certified Public Accountant
Kevin is a CPA with over 28 years of experience. He helps Individuals and Small Businesses pay the least amount of tax legally possible, and providing peace of mind that their returns are prepared accurately.