PRESIDENT

Founder of Pointerro, LLC

With over 8 years of experience in Regulatory and Regulatory Operations consulting, Tim established Pointerro, LLC in 2022 to offer unparalleled support to his clients. His extensive knowledge of domestic regulations, guidance, and policies enables him to effectively assist sponsors with regulatory submissions life-cycle management, e-publishing/e-transmission, FDA interactions (including liaising with the FDA on behalf of sponsors), and regulation/guidance interpretation.

Tim holds a Master of Science and Health Science in Regulatory Affairs from The George Washington University, which he obtained in 2020. He is an expert in MS Word (.doc) and an expert user of Adobe (.pdf). Additionally, Tim is a trained docuBridge TWO (.xml) viewer/publisher/administrator, making him a versatile and invaluable asset to his clients.

US FDA REGULATORY DOCUMENT EXPERT

Cina has 20+ 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.).

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.

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.