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Product Development and Regulatory Approval of In-Vitro Diagnostics and Companion Diagnostics
PhD in Biochemistry, MBA in Business and RAC (US) Certification with 15 years of experience in diagnostic assay and system development at top global in-vitro diagnostic (IVD) companies including Roche, Bio-Rad Labs, Siemens Healthcare Diagnostics and Employer. A proven track…
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…
Organic and Medicinal Chemistry
Expert has expertise and broad knowledge in Synthetic Organic Chemistry of various classes of compounds coupled with experiences and adept characterizing compounds using various NMR techniques 1-D and 2-D (COSY, HMBC, TOCSY, ROESY) diverse analytic techniques for compounds purification, use…
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…
DMA/DMTA testing of composites and polymers. Thermal conductivity/resistivity of most materials.
Since the late 1970s Expert has been using and developing DMA/DMTA and also using other thermal analysis techniques too particularly for testing polymers and composites. 1976 to 1981 with Du Pont Instruments then PL thermal Science from 1981 to 1994.…
Assay Development, Bioanalytical Chemistry, Validation, Intellectual property
The expert has extensive experience writing proposals, résumés, cover letters, CVs, grant applications, provisional patent applications and technical publications. Additionally the expert has experience in the areas of assay development, bioanalytical chemistry and food and agricultural products testing.The expert has…
Medicinal Chemistry, Synthetic Organic Chemistry, Drug Discovery, Pharmacokinetics
Expert has strong knowledge in asymmetric multi-step organic synthesis, scaffold design and library development with ability to solve challenging chemistry problems and have authored peer-reviewed articles and patents. Expert is a synthetic and medicinal chemist with over 13 years of…
Medicine and Biotech Materials, Polymers, Nanoparticles, Peptide and Protein Chemistry
Expert has a MSc in chemical engineering and a PhD in pure and applied biochemistry. Her PhD thesis was on enzyme technology (enzymatic synthesis) and molecular imprinting (preparation of chiral liquid chromatography stationary phases). Expert carried out postdoctoral studies in…
Hazardous Materials, Retrospective Toxic Chemical Exposure Assessment, Mold, Hazard Communication
Results oriented environmental scientist with over 35 years of experience providing consultation and litigation support in the fields of, industrial hygiene, retrospective toxic exposure assessment, indoor air quality, indoor mold contamination, hazardous consumer and industrial products, chemical hazard communication, labeling…
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…