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Regulatory Affairs Support for Success

Arciel's Team*


Raymond Lamy

Raymond C. Lamy, MS

US FDA Regulatory Expert

Arciel, LLC

Ray 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.

Cina Salas

Cina Salas

US FDA Regulatory Documentation Expert

ENERO, LLC

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.

Nico Batang

Nico Batang

US FDA Regulatory Documentation Specialist

ENERO, LLC

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.

M. Currie Consulting

Michelle Currie

Medical Writer

M. Currie Consulting

Michelle 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.

Deborah Jezior

Clinical Operations Consultant

DA Jezior Consulting

Deb has worked in the pharmaceutical industry in both CRO and sponsor companies for over 24 years. She has successively held positions from CRA through various levels of management from the CRO perspective, and has managed and overseen the clinical programs from the sponsor side, including building clinical operations departments in both types of organizations. Her main therapeutic areas include oncology, CNS, and infectious disease.

Kristine M McGraw

Kristine M. McGraw, PMP

Project Management

DTS, LLC

Kristine is a data management professional with 20+ years' experience across multiple types of businesses. She's demonstrated strengths that include project management (PMP certified), assessing organizational needs, understanding business objectives, and implementing initiatives that enhance corporate performance at a growing company.

Timothy Johnson

Timothy C. Johnson, MSHS, CCRP

US FDA Regulatory Affairs Specialist
US FDA Regulatory Documentation Specialist

Arciel, LLC

Tim is a Regulatory Affairs Professional with growing experience in the Pharmaceutical Industry. Skilled in successfully managing and planning submissions, as well as authoring high-quality regulatory documents. Knowledgeable in relevant domestic regulations, guidance, and policy with insight into site-level operations. He obtained a Master of Science and Health Science in Regulatory Affairs from The George Washington University in 2020 and is a Microsoft Office Specialist - Expert.

Justin Lamy

Justin C. Lamy

US FDA Regulatory Affairs Intern

Arciel, LLC

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.

Abigail Johnson

Abigail R. Johnson

US FDA Regulatory Affairs Intern
Medical Writing Intern

Arciel, LLC

Abby is pursuing a Bachelor of Science in Allied Health Sciences with a concentration in Public Health and Health Promotion and a minor in Psychology at the University of Connecticut. Additionally, she has obtained her human subjects and biomedical research certification from the Collaborative Institutional Training Initiative (CITI) and is pursuing further research opportunities. In this internship, she hopes to gain experience in regulatory affairs and medical writing. She previously interned at the Trumbull Health Department in Connecticut focusing on disease prevention and community health.

* The consultants listed here are available under Arciel, LLC's consulting agreement.