Timothy C. Johnson, MSHS
President & Lead Consultant
Arciel, LLC
Tim established ARCIEL, LLC, of Connecticut, in 2022 and brings 5+ years of experience in Regulatory / Regulatory Operations consulting to support ARCIEL’S clients. Tim is knowledgeable in relevant domestic regulations, guidance, and policy to assist sponsors with regulatory submissions life-cycle management, e-publishing / e-transmission, FDA interactions (including liaison with FDA on behalf of sponsors), and regulation / guidance interpretation. He obtained a Master of Science and Health Science in Regulatory Affairs from The George Washington University in 2020, and is an expert MS Word (.doc) user, intermediate Adobe (.pdf) user, as well as a trained docuBridge TWO (.xml) viewer/administrator.
Raymond C. Lamy, MS
US FDA Regulatory Expert
Arciel, LLC
Ray established ARCIEL, LLC, of California, in 2008 after several years of industry experience at pharmaceutical, biotech and international consulting companies. He brings 35+ years of pharmaceutical industry experience to best support sponsor drug development and regulatory submissions by providing high level expert consulting in US regulatory operations. This includes regulatory submissions life-cycle management, FDA interactions (including liaison with FDA on behalf of sponsors), regulation / guidance interpretation, and strategic planning.
Cina Salas
US FDA Regulatory Documentation Expert
ENERO, LLC
Cina has 19+ 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/TWO (.xml) software and provides word processing and e-publishing support for compliant eCTD submissions as well as e-transmission through ESG. She also maintains e-dataroom (SharePoint, ShareFile, BOX, DropBox) regulatory files (IND, ODD, etc.).
Nico Batang, MEd
US FDA Regulatory Documentation Specialist
ENERO, LLC
Nico is proficient in MS Word (.doc), Adobe (.pdf), and docuBridge TWO (.xml) software and provides word processing, e-publishing and QC support to ensure that documents are eCTD-ready for regulatory submissions.
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.
Abigail R. Johnson
US FDA Regulatory Affairs Senior Intern
Medical Writing Senior Intern
Arciel, LLC
Abby obtained a Bachelor of Science in Allied Health Sciences with a concentration in Public Health and Health Promotion and a minor in Psychology from the University of Connecticut in 2022. She previously interned at CooperSurgical, Inc. as a Regulatory Affairs intern. In this internship with ARCIEL, she hopes to gain more experience in regulatory affairs and medical writing. She is an associate MS Word (.doc) and Adobe (.pdf) user, as well as a trained docuBridge TWO (.xml) viewer, providing valuable assistance in word-processing, PDFing and QCing regulatory submissions.