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Expert ID: 733424 Pennsylvania, USA

Expert in 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…

Expert ID: 732491 Washington, USA

Expert in Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices

Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…

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: 725448 Colorado, USA

Expert in Pharmaceutical Facilities, Pharmaceutical Manufacturing Processes, Facility FDA Compliance

In addition to having primary responsibility for numerous pharmaceutical construction projects over the last 15 years, Expert has also held several positions with pharmaceutical and medical device companies where he was responsible for the daily operations of facilities engineering, maintenance,…

Expert ID: 723691 Florida, USA

Expert in Pharmaceutical Manufacturing, Research and Development, Education & Training

Expert’s primary experience in tablet manufacturing covered conventional pharmaceutical tablets for a variety of drugs and chewable tablets of antibiotics, utilizing both Expert and wet granulation techniques and a variety of processing and tablet equipment. His experience encompasses all aspects…

Expert ID: 723693 Florida, USA

Expert in Pharmaceutical Science; Preformulation, Development, Chemistry, Manufacturing & Control (CMC) Issues; Paragraph IV Hatch-Waxman & Canadian Notice of Allegation

As the development of a pharmaceutical reaches Phase 3, prior to submission of an NDA, method validation is required. Validation is a demonstration of optimization. By demonstrating the capacity of a method within the bounds of validation, optimal conditions for…

Expert ID: 735625 South Carolina, USA

Expert in Pharmaceutical and Fine Chemicals, Small and Large Scale Manufacturing

I earned my PhD at the Technical University (TU) of Karlsruhe, Germany in Organic Chemistry. I have knowledge and experience in the following realms: - Phospholipids - Pharmaceuticals (R&D, Manufacturing) - Vitamins. Highly motivated, results oriented professional with over 35…

Expert ID: 733859 Arizona, USA

Expert in Manufacturing technologies for Pharmaceuticals, Biologicals, Biotech and Vaccines

Expert is an independent consultant to bio-pharmaceutical, medical device and vaccine manufacturers, associated equipment suppliers and investors, with over 40 years experience in aseptic process technology, new product and business development, marketing strategy and regulatory compliance for manufacturing of pharmaceuticals…

Expert ID: 734489 Texas, USA

Expert in Transportation, Energy, Manufacturing, Chemical and Petrochemicals, Pharmaceuticals, Wood Works, Healthcare, Education, etc.

With 23 years of providing clients quality and innovation, expert runs a local-to-national firm executing work within 7 distinct (related) NAICS codes. Identifying, addressing, and improving environmental, and IH conditions across industry; client objective-scoped; cost efficient; ethically driven to serve.…

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…

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