Pamela Wertalik

About Pamela Wertalik

Award-winning, former FDA Consumer Safety Officer with extensive knowledge and experience in the FDA Regulated Industries including the Pharmaceutical, Medical Device, Biologics, Laboratory, Dietary Supplements, Cosmetics and Food Industries. Demonstrated ability with complex regulatory, quality and technical issues, products, and processes. Solid Quality Assurance and Regulatory Compliance background including with QSR, GMP, GCP, and GLP. Proven management capabilities as an Industry Consultant, Industry Manager, Corporate Quality and founder/CEO of online B2B platform ContractLaboratory.comFounded and sold science and laboratory related B2B ContractLaboratory.com.

Experience

1. CEO Founder Consultant

   Cdmo World

   Jan 2000 — Present

   Global Regulatory is a consulting firm that specializes in the US Food and Drug Administration FDA regulated pharmaceuticals, combination products, biologics, medical devices, dietary supplements, cosmetics, clinical trials, and food industries.

Education

• Rutgers University

  BA, Biology

  1986 — 2000

Skills

• Regulatory Affairs
• Lifesciences
• Medical Devices
• Quality System
• Clinical Trials
• Product Development
• Technology Transfer
• Laboratory
• Biotechnology
• Biopharmaceuticals
• Research and Development (R&D)
• Quality Assurance
• Entrepreneurship
• Start-Ups
• Gmp
• U.s. Food and Drug Administration (Fda)
• Life Sciences
• Management
• Technology
• Science
• Marketing
• Pharmaceutical Industry
• Fda
• B3b
• Innovation
• Commercialization