Find an Expert
Bioprocess Development
Expert specializes in the development and selection of recombinant protein expression platforms, translating discovery candidates into development programs and the generation of preclinical material. She has successfully built infrastructure, incorporated process improvements and identified innovative approaches for development. She effectively…
Large Animal pharmacology/pharmacokinetics, Sterile products,GMP,Product Development, Safety and ID
Expert has training is antimicrobial monitoring and reporting to Blue Cross/Blue Shield of hospital infectious diseases. She is an occupational safety officer for laboratory animal programs and a pharmacy safety instructor. She has completed GMP training to include auditing in…
Neurotechnology, Brain-Computer Interfaces, Neurological and Neurosurgical Medical Devices
Dr. is a Neurologist and Translational Neuroscientist at Employer since July 2011. He was a Neurologist and Translational Neuroscientist at the University of Pennsylvania, a position he has held from July 2010 to June 2011. Dr. earned the MD and…
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…
wound healing, burns, clinical research, FDA regulations, drugs, devices, medical writing
Expert provides scientific knowledge and regulatory background to assist companies in the research and development of clinical, animal and laboratory studies designed to promote pharmaceutical drugs and medical device products specializing in wound healing and burn care. Additional Services: •Development…
Pathogen Detection, Rapid Methods, Food Preservation, Antimicrobial Effectiveness Testing, Herbs
Expert has extensive experience (20+years) in food microbiology research including molecular pathogen detection methods and antimicrobial effectiveness testing. She has provided technical leadership and contributed expertise to develop and evaluate DNA-based methods and immunoassays for detection of pathogens including E.…
Computer Aided Design, Finite Element Method, Mechanical Engineering, Biomechanics
Expert is the Director of the Medical Engineering Research Group at Employer and a Senior Lecturer in Mechanical Engineering. Since completing her PhD in 2001, she has been applying mechanical engineering solutions to medical problems, mainly in orthopaedics. Expert's research…
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…
Clinical Diagnostics, Immunoassay Product Development, Clinical Toxicology
Expert has two major areas of Expertise: 1) He has been involved in all aspects of In Vitro Diagnostic Immunoasasy and Clinical Chemistry Product Development Including Laboratory Research and Development, Transfer to Manufacturing, Documentation to meet QSR including Design History,…
Chemical and Pharmaceutical Development – Comprehensive CMC
Expert has worked on research, development and manufacturing problems involving stereochemistry throughout his academic training and industrial career. Relevant examples include: development of scalable chiral and asymmetric syntheses; improvement of reaction stereoselectivity; tracking of chiral integrity in chemical processes; chiral…