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Systems and Processes in Clinical & Regulatory in Pharmaceutical, Healthcare and Health Insurance
Accounting ethics | Expert is a CPA, member of AICPA and NYSSCPA. Expert has global experience with pharmaceuticals, focused on corporate integrity agreements and Physician Payment Sunshine Act, interacting with finance, audit, clinical and regulatory teams, physicians and non-physician investigators,…
Biotechnology & Pharmaceuticals: Drug Development, Due Diligence, Strategy, Finance, Market Analysis
With an MD-PhD, clinical training, ten years of experience analyzing and investing in companies developing drugs, ex[erience as a CEO of both private and public biotechnology companies, Expert has seen the drug and biotechnology industries from many angles. As an…
Pharmaceutical Product Development, Dosage Forms, Controlled Release, QC/QA, GMP, China
Expert has worked in the pharmaceutical industry as a research scientist, QC/QA director, vice president of product development, and has been involved in product development from pre-clinical through Phase 1 production. Expert has experience in setting up a cGMP manufacturing…
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…
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…
Personal Care and Household Products
Expert has experience in the formulation, manufacturing, and marketing of the listed household products (among others) to the retail industry. He has experience and knowlege in manufacturing and U S Food and Drug Agency regulations. He also possesses experience in…
Drug Regulatory Affairs (European Union)
Expert has nearly 20 years experience in Drug Regulatory Affairs (RA). Before setting up his own RA consultancy in June 2008, he has worked in various senior RA positions in the pharma and biotech industrie having been located in Germany,…
Pharmaceutical/Biotech Marketing | Brand Marketing | P&L Management | Commercial Strategy
Expert is a strategic advisor to the life sciences industry drawing on more then 25 years of sales, marketing and managed markets experience in commercial healthcare organizations. He has worked both as client and vendor (pharma/biotech executive and ad agency…
Life Science, Biotech, Pharmaceuticals: Research and Development, Smart Manufacturing/ Supply Chain, and Market Launch/ Commercialization
Expert has over 20 years of experience in strategic innovation, system building, and delivering value solutions for global markets. His focus is on building infrastructure synergies between science, technology, and finance. As a Strategic Advisor, he has experience with: •…
Biomaterials, Drug Delivery, Tissue Engineering, and Regenerative Medicine
Expert is an internationally recognized expert in biomaterials development, drug delivery (e.g., protein, plasmid DNA, etc), tissue engineering, and regenerative medicine. Expert, PhD, received his B.S.E. in Mechanical Engineering and Material Science and Biomedical Engineering, cum laude, from Duke University…