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Expert ID: 736123 Indiana, USA

Expert in Medical Device Quality Assurance and Regulatory Compliance

Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…

Expert ID: 733372 New York, USA

Expert in Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing

Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…

Expert ID: 732460 Maryland, USA

Expert in 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…

Expert ID: 731331 Illinois, USA

Expert in CGMP,Pharmaceutical Manufacturing and Operational Excellence

Expert has over thirty (30) years of experience in the area of pharmaceutical manufacturing, pharmaceutical research and development, outsourcing, operational excellence and cGMP. Expert has broad ranging experience in pharmaceutical development, manufacturing and outsourcing that includes basic research in the…

Expert ID: 731170 New Jersey, USA

Expert in Statistics (Pharmaceuticals (CMC): Design of Experiments, Process Validation, Stability)

After receiving a Expert in statistics, expert has worked in the pharmaceutical industry for over 30 years as a non-clinical statistician applying statistical methodologies, performing data analysis, and interpreting results with scientists in research and development. He collaborated with scientists…

Expert ID: 729566 Illinois, USA

Expert in Food & Drug Administration Rules, Policies, Procedures for Medical Devices and Pharmaceuticals

Expert is an FDA compliance expert with 28 years experience in the field. He served the U.S. Food and Drug Administration as an Investigator concentrating in compliance for pharmaceuticals and medical devices as well as pre-market development of drugs and…

Expert ID: 729349 Michigan, USA

Expert in Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization

Technological / Scientific Infrastructures Speed to Markets • Advising and Strategically Coordinating with the Following Agencies:  World Health Organization COVID-19 Accelerator Cure Project  Linking Collaboration Platforms for Best in Class Teams around the world  The Directorate for…

Expert ID: 728147 Jordan

Expert in Food Science & Technology

Expert is currently a Food Science & Technology Consultant and employed in the private food sector in Jordan. He is an active member in many technical committees for food in JFDA, JISM and Ministry of Environment, and the Ministry of…

Expert ID: 728090 Switzerland

Expert in Pharmaceutical Development, strategy planning and execution

Expert graduated in Biology at the University of Utrecht, The Netherlands, in 1984. From 1985-89 he was a PhD student at the University of Basel. The research in the field of gene regulation was carried out at the Friedrich Miescher…

Expert ID: 726016 New Jersey, USA

Expert in Biotech, Pharma and Medical Device Product and Process Development, Scale-up & Commercialization

His approach to process validation is that PV begins at the process development phase. A process that is well understood, well defined as per the critical to quality attributes with an understanding of the variable interactions prior to the definition…

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