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Process Inorganic Chemistry and Liquid Solid Crystallization and Fluid Bed Processes
He was deeply involved in a large segment of inorganic chemistry within SOLVAY who is a major actor (3 billions Euros turn over in inorganic chemicals). Expertise area covers most of steps of processes with special emphasis on crystallization: liquid…
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…
Drug Delivery, Formulation Development of NCE\’s, Pre-formulation, Stability, and Clinical Manufacturing
She has been involved in contract manufacturing of pharmaceuticals for the drugs and devices. Contract manufacturing for drugs have included identification, evaluation, screening and selection of CRO's and CMO's in the area of sterile solution and oral solids. For the…
Information Technology and Cyberlaws, Intellectual Property and Commercial Laws Practice
Expert has successfully advised clients on conducting business online and ensuring all legal compliances have been made. She has suggested better models of doing business through e-commerce and assisted in developing new e-marketing tools and models for a web business.…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Healthcare, Medical Device, Diagnostics, Pharmaceuticals coding, reimbursement
Expert, MD FACP AGAF FASGE FACG is a physician whose focus is strategy for coverage, reimbursement, quality improvement, bundled payments and accountable care. Executive clinician with over 30 years of experience providing strategic leadership and medical oversight to data-driven health…
Biopharmaceutical Development
Expert, PhD, is a consultant in the field of BioPharmaceutical Development. He has over 23 years of biotech industry experience in biotherapeutic and diagnostics development, having held senior positions at several biotech companies, most recently, VP of Biologics Development at…
In-Process Analytical, cGMP Auditing, Polymer Characterization, Analytical Lab Design and Management
Expert has 32 years of industrial analytical chemistry experience. For the last 24 years of that period, he headed the analytical R&D organization of International Specialty Products, a $1.7B specialty chemical company (as of 2007). In his time heading that…
Clinical Development Processes and Clinical Trial Technologies
Expert has worked extensively in bringing technology solutions to solve inherent problems of clinical trial processes. The software products he has worked on ranges from 'electronic data collection' to 'document centric' solutions to reduce overall time it takes to bring…
Hazardous and Solid Waste Management, Waste to Energy, etc.
Expert has worked on hazardous waste management for more than 8 years. She is an expert at management, characterization, treatment, and disposal of industrial hazardous waste at a hazardous waste treatment and disposal facility. She has experience of handling wastes…