Expert Directory
Having an expert witness or consultant at your side can help you navigate complex situations with confidence. These professionals understand your industry and excel at conveying crucial information, whether in a courtroom or a consulting environment. At Intellex, we have experts in over 30,000 areas in our database. We enable you to partner with an individual who has the knowledge, educational background, and relevant experience to support your needs effectively.
Utilize our expert finder tool to handpick the ideal mentor or consultant for your specific application.
CPG Quality Assurance & Compliance (cGMP/FDA Regulated Industries) & Industrial Microbiology
Expert is a quality and manufacturing operations professional with 30 years of career experience as an organizational leader, technical program manager, and quality professional within the global consumer goods industry, having worked across Latin America, Europe, and North America for…
Pharmaceutical Regulation, FDA Compliance & Inspections, Sterile Compounding, Quality Systems, and Regulatory Science
Expert is a board-certified pharmacist and regulatory science professional with over two decades of combined experience in pharmaceutical compliance, inspectional oversight, and sterile compounding practice. Throughout an extensive career with the U.S. Food and Drug Administration (FDA), Expert has conducted…
Medical/Pharmaceutical R&D and Manufacturing – New Product Approval and Launch Including FDA, EMA, and Asia
With over 40 years of experience spanning design, manufacturing, R&D, and regulatory compliance, the expert has established a distinguished career in the medical and pharmaceutical industries. Over the past two decades, he has spearheaded numerous successful projects resulting in more…
Medical Device Quality Assurance and Compliance, FDA Medical Device Regulations, Quality Management Systems, Lean Six Sigma, Certified Six Sigma Master Black Belt
Expert is an extensively knowledgeable, self-motivated, and result-oriented Biomedical Engineer with an extensive background in quality and reliability engineering. Interested in verifying and validating solution designs, including detailed quality metrics in maintaining quality management systems that support and improve processes,…
Pharmaceutical Regulatory Affairs; FDA/cGMP Compliance; Drug & Device Regulatory Submissions; Regulatory & Quality Systems Consulting; Expert Witness
Expert is a pharmaceutical regulatory affairs professional with more than three decades of experience combining industrial R&D, business development, quality assurance/quality control, and regulatory consulting with formal tenure at the U.S. Food and Drug Administration. Expert holds a Master of…
BioStatistics, Pharmaceutical Devices, Biotechnology, and FDA and EMA Submissions
Expert holds a Ph.D in Statistics and has 25 years' applicable industry experience. He currently serves as a biostatistical expert witness in high-stakes pharmaceutical and medical device litigations. He has expertise in pre- and non-clinical, Phases I-IV in biostatistics, data…
Pharmaceutical Manufacturing Processes, Quality Management, and FDA Interactions
Expert is a consultant to the US FDA for Quality issues associated with the manufacture of pharmaceuticals. Expert is a subject matter expert for the US FDA in Warning Latters and Consent Decree work and data Integrity issues. Expert provides…
Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
FDA Regulatory Expert Witness Regarding Medical Devices, Drugs, Software and Data Integrity
Skilled at writing expert reports that describe and explain regulatory and compliance-related issues involving FDA-regulated companies. Talented in depositions and testimony. Specialist in analyzing drug/medical device-related safety data and FDA compliance information to answer three questions: 1) What did the…
Pharmaceutical & Medical Device Program and Portfolio Management
Expert is an experienced program and portfolio management leader with a strong track record of delivering pharmaceutical and medical device assets, combining strategic and critical thinking with a passion for coaching and mentoring teams. Expert has experience across multiple disease…