 |  | Expert 722793
| | Expert in Polymer Chemistry and Processing Related to Softgel Technology, Pharmaceuticals, and Medical Devices
Expert 722793 worked for over 15 years in biomedical polymer research, first in contract research to synthesize, process, and characterize biocompatible polymers, and then in medical device R&D doing polymer characterization support for new IV catheter material projects. He also worked worked for over 10 years in all areas of softgel capsule manufacturing. His expertise there includes formula development, process quality improvement, new product development, and manufacturing technical service in pharmaceutical capsules and paintball manufacturing. | |  |
|  |  | | Expert 722568
| | Expert in Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As head of clinical research for four different organizations, Expert 722568 oversaw development efforts which led to the approval of six new chemical entities (NCEs) by the FDA. These included anti-fungal, allergy, immunomodulating, anesthesia, and pediatric apnea control products. He also oversaw the development of three generic drugs. | | |
| |  | | Expert 722341
| | Expert in Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation
Expert 722341 has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. He has also assisted in the design of pharmaceutical manufacturing facilities and processing systems for the manufacture of parenteral products. He brings both practical production and quality assurance perspectives to the evaluation of drug processing facilities and systems. | | |
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