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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…
Rheology, Nanotechnology, Particulate/Multiphase Processes, Chemical Engineering.
Expert operates his contract research & development small business incorporated in 1990 in Saint Paul, Minnesota, USA. Expert's professional experience spanning over four decades in chemical engineering has focused around the broad areas of particulate/multiphase processes and rheology. Chemical engineering…
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…
Nanotechnology
Expert has a decade of experience synthesizing, characterizing and applying nanoparticles for various applications. He has used many scientific instruments for characterizing nanomaterials like transmission electron microscopy, scanning electron microscopy, UV-Vis spectroscopy, fluorescence spectroscopy, Thermogravimetric analysis, dynamic light scattering, x-ray…
Product Development, Quality Assurance, GMP Audits, Qualifications, Troubleshooting, Pharmaceutical, Nutraceutical, Production Issues, GMP Compliance, Pharmaceutical Dosage Forms, Quality Control
Expert has more than 24 years of experience Internationally (New Zealand; Australia; Oman, and India) in pharmaceutical formulation plants, Product Development; Analytical development; Scale-up, Technology transfer; Manufacturing, Quality Assurance; quality control (testing and releasing); Lead regulatory audits and meet the…
Nanotechnology, Biomaterials, Sol-gel Sciences, Optics, Biotechnology, Glass, Ceramics, Spectroscopy
Expert is a specialist of sol-gel chemistry. He developed a new non-aqueous method for sol-gel glass coating to obtain transparent films for integrated optics and photonics using polysiloxane materials. The aim was to obtain low-softening temperature glasses to permit facile…
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…
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…
Pharmaceutical Development, CMC, Project Management, Intellectual Property
Expert has developed modified release products throughout his career. Most recently he led the development of proprietary oral modified release systems at Phoqus Pharmaceuticals. These included zero-order, increasing-rate, pulsatile, delayed-release, chronotherapeutic and fast-release formulations. Prior to that he was responsible…