PharmaBioServ assembled the Regulatory and Compliance Advisory Board to provide our clients with the best advice for their regulatory and compliance needs based upon all the knowledge, experience, and good professional judgment from the board members.
The Advisory Board is composed of former FDA officials, ex-industry members, and FDA practice lawyers.
A senior business leader offering practical solutions to Business Processes and Compliance/Quality improvements. Edwin is a professional with more than 20 years in senior leadership positions in Big Pharma organizations going through significant Operational and Compliance/Quality remediation. Consistently exceeds goals and expectations by aligning structure, systems and technology, building high performance teams to drive sustainable improvements.
Passionate about individuals and team’s development, assisting them meeting and surpassing their goals.
Edwin holds a Bachelor of Sciences in Chemical Engineering and an MBA from the University of Puerto Rico.
Maridalia Torres is a proven professional with over 35 years of regulatory experience, and demonstrated organizational and sound decision-making skills. She is politically savvy and goal oriented, a proven communicator with extensive experience in US FDA regulatory compliance and enforcement across the full range of products regulated by the US food and Drug Administration.
Served as Director of the Food and Drug Administration’s San Juan District Office and was part of the Office of Regulatory Affairs Senior Management from October 2006 to January 2018 with responsibility over FDA's overall operations in Puerto Rico and US Virgin Islands.
More information at: matorres@pharmabioserv.com.
Domenic J. Veneziano is an Independent FDA Regulatory and Strategic Consultant and owner of Veneziano Consulting, LLC. A 24 years veteran of the U.S. Food and Drug Administration (FDA) and U.S. Public Health Service (USPHS), Domenic served as the Director of Import Operations in the Office of Regulatory Affairs.
As a senior FDA leader he had prominent roles in the oversight of FDA’s National import operations program, including the development and implementation of FDA’s Targeting System PREDICT and the Import Trade Communication System (ITACS), the integration of Customs and Border Protections Automated Commercial Environment (ACE) with FDA’s systems, and the new Food Safety Modernization Act (FSMA) and Food and Drug Safety and Innovations Act.
Irving L. Wiesen, Esq. is a food and drug attorney with over thirty years experience in the industry. He specializes in food and drug law and other laws and regulations affecting the pharmaceutical, biotech and medical device industries. His practice includes counseling pharmaceutical and medical device companies in all areas of FDA compliance, drug marketing and promotion, drug applications, product importing, representation before the FDA, as well as licensing, R&D agreements, commercial transactions and litigation.
Mr. Wiesen serves on the advertising review boards of several pharmaceutical companies to ensure that their marketing and promotion complies with FDA regulations. In addition, he has filed successful applications to the FDA on behalf of medical device companies, and obtained marketing clearance for devices in the fields of cardiology and others.
More information can be found on the website: www.wiesenlaw.com
The knowledge, skills and experience brought by our Advisory Board Members provides extremely valuable insights, compliant solutions, and the assurance of well taken decisions.
Regulatory Compliance, Quality & Technology Professional Consulting Services for highly-regulated industries worldwide.
