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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…
Pharmaceutical Quality Assurance, Quality Control, Supplier Selection and Supplier Quality
Expert has extensive expertise in GMP matters in the pharmaceutical and medical device industries. During his 20 years in industry, he devised, managed and led programs to assure compliance to drug GMPs, GLPs and GCPs. Key areas of expertise included…
Near Infrared Spectroscopy, Multivariate Analysis, Pharmaceutical Analysis, (GMP)
Expert is an internationally recognized expert in pharmaceutical analysis, regulatory compliance, laboratory management, design quality, and process analytical technology using spectroscopic methods, including near-infrared and multivariate analysis. Nineteen years of industry experience with increasing responsibility and five years of policy…
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…
Microbiology, Infection, Infection Control, Occupational and Hospital Hygiene, Biohazards, and Needlestick
Expert offers a highly valued research-driven consultancy specializing in healthcare, environmental, and occupational microbiology, waste management, and bio-safety. With a strong science-based research record in these areas, and a background in NHS and University Medical Schools, he has over 35…
Analytical Optical Spectroscopy, Chemometrics, Petroleum, Polymorphs and Diagnostics
Expert has taught courses and performed investigations in many areas of analytical chemistry including analytical spectroscopy, qualitative analysis, quantitative analysis, computer programming methods, algorithm developments and instrument developments. The primary goal of his research is to develop practical analytical instrumentation…
Pharmaceutical, Chiral Chromatography; Chiral Separation; Chromatography Methods Development
Expert has 30+ years of analytical experience in pharmaceutical industries. She worked as an analytical scientist in Glaxo SmithKline and Johnson and Johnson. Her specialty is to develop analytical methods to support drug discovery and drug development groups. Her expertise…
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…
Pharmaceutical Formulations, Nutraceutical Formulations
Expert is an expert in developing multi-source drug formulations and generic equivalents of innovator products. To date, he has developed and put into the international market more than 100 such products. Consultant to Zim Laboratories Ltd. from 1994 to 2000…
Life Sciences, Lab IT Support & Validation
Worked as a group leader as well as R & D Sr.. scientist. Expertise in analytical method development and testing. Worked with NDA and ANDA products with different clients. Directly communicating with clients regarding progress and any problems in development…