Our experts have over three decades of experience in the medical device and drug product regulatory environment, providing expert support to companies regulated by the U.S. Food and Drug Administration (“FDA”) and global regulatory bodies. We have a team of experts to help you meet your needs. The Regulatory Services group of professionals averages 25 years of experience, from employment at the FDA to holding senior positions in the life sciences industry. The group offers unparalleled expertise in developing and implementing regulatory strategies at each stage of the product development as well as anticipating and managing regulatory compliance issues that may arise based on enforcement and technology trends.
Our Senior Team members:
T. R. PAPSON, FOUNDER AND PRINCIPAL CONSULTANT
Trudy Papson is a co-founder and former FDA Investigator with the USFDA for over 12 years. She received the Department of Health Services highest awards as a medical device Investigator. As Recall Coordinator she oversaw and worked with industry on serious public health threats and related problems with international significance. She is experienced in Pre-and Post Market Approval, Compliance inspections, BIMO/Clinical Investigators and Sponsor/Monitors, assisting in CAPA, MDR, Labeling and Compliance responses.
LAURA REID, PhD, RAC - SENIOR ASSOCIATE
Laura Reid, PhD has over 12 years experience in pharmaceutical, medical device, diagnostic development and clinical trials industry. Her experience includes working as a Senior Readiness Inspection Auditor of a Clinical Research Organization (CRO) where she hosted numerous sponsor audits of clinical studies. She prepared audit plans, conducted vendor management audits, qualification and re-qualification audits, ensured compliance with quality standards and Study Plans, analyzed investigation results, reviewed protocols, TMFs for compliance, CRFs and other documentation for GCP/GLP compliance. Dr. Reid is an expert in clinial laboratory operations, is RAC Certified and has a PhD in Genetics.
CHRISTINE PARMENTIER - SENIOR ASSOCIATE
Christine Parmentier is a retired Commissioned Corps Officer of the United States Public Health Service who worked for the FDA for approximately 20 years. For the first seven of those years, Ms. Parmentier worked as a Nurse Consultant for the Office of Surveillance and Biometrics at the Center for Devices and Regulatory Health in Rockville, MD. In August of 2000 Ms. Parmentier relocated to San Jose, CA where she began work at the San Jose Resident Post of the San Francisco District Office as an Investigator inspecting medical device manufacturers. She became part of the International Inspection Cadre in 2003 and as such performed inspections of the medical device industry abroad as well as domestically. Ms. Parmentier holds a Bachelor of Science in Nursing degree from the University of California School of Nursing, San Francisco and a Master of Public Health from the School of Hygiene and Public Health of Johns Hopkins University. Ms. Parmentier recently retired after 25 years of service with the Federal Government.
FREDERICK MAYER - SENIOR ASSOCIATE
Fred Mayer has thirty-seven years of experience in pharmaceutical manufacturing management, Quality Assurance and Project Management to include facility start up and validation, development and implementation of Quality Systems and procedures, US and international audits of Pharmaceutical, Research and Development, Active Pharmaceutical Ingredient and Device facilities, FDA Pre Approval, General Inspection and International Inspection preparation.