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Expert ID: 725163 Florida, USA

Expert in Medical Device Regulatory Support, Medical Device Registration, etc.

Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…

Expert ID: 729312 India

Expert in Regulatory Affairs/Registration Consultancy for Medical Devices/Drugs/IVDs/Food in Indian Market

Expert with a post graduate degree in Chemistry has been part of the team in the CDSCO, Government of India for framing of the Import Registration requirements for Drugs, Medical Devices and IVDs. Expert was the Medical Devices Reviewer for…

Expert ID: 107649 Oklahoma, USA

Expert in Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness

Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…

Expert ID: 723903 North Carolina, USA

Expert in Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews

Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…

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: 735921 Georgia, USA

Expert in 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,…

Expert ID: 732176 California, USA

Expert in Food Labeling; Food, Spring/Bottled Water, Drug and Medical Device Good Manufacturing Practices

Expert was a California Food & Drug Investigator for 26 years enforcing federal GMPs and California health & safety codes. She has traveled throughout California inspecting a wide range of wholesale food, drug, and medical device manufacturers. She was responsible…

Expert ID: 731785 India

Expert in Medical / Laboratory Device Distribution Management; Consumer goods, Retail segment in India

Having been a part of this domain for over 25 years we have now taken up an advisory role. As consultants we provide a comprehensive search for distributors to any consulting organisation like yours / when a foreign mfr wants…

Expert ID: 731095 California, USA

Expert in Medical Product Design and Development

I have nearly 20 years professional experience with product development and manufacturing. This is ignoring the extensive experience I gained in my own time beginning at a very young age. For example, by age 10 I was experimenting with lasers…

Expert ID: 730258 California, USA

Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software

Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…

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