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Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software
Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…
Pharmaceutical Formulation, Drug Delivery, CMC, NDA, and Formulation Patents
Expert has developed multiple immediate release and modified release oral formulations at ALZA Corporation and at Transcept Pharmaceuticals. Many of these formulations have been commercialized including Invega (OROS paliperidone) and Exalgo (OROS hydromorphone). Recently, Expert was instrumental in developing a…
Improving the Value of Technology Investments, Management of IT and Application in Business
Expert. Expert has a successful track record helping clients to develop and improve the management and application of technology within their businesses; bridging the Business/Technology divide by deploying eclectic, hybridised commercial & technology skills and experience. Expert is fully capable…
Pharmaceuticals, Biotechnology
Expert is an independent consultant providing management solutions for science and technology in the pharmaceutical and biotechnology industries. His background includes over 25 years of pharmaceutical industry experience with positions of increasing responsibility at Astra, Warner Lambert/Parke-Davis and most recently…
Managing the Interface Between Owners and Engineering Contractors
Expert has successfully directed engineering and construction projects with values up to $700 million, primarily in the U.S. Working directly for the Owner, he most recently completed a $200 million project, 5% under budget and 2 months ahead of schedule,…
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: •…
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…
Regulatory Sub. NDS, ANDS, SANDS, NC, Cross References, Natural Health Products, Medical Devices
Expert's firm has extensive expertise in regulatory submission. They provide different regulatory strategies to their customer’s and prepare all types of submissions on their behalf. Expert also has extensive expertise in Narcotic’s regulations. Moreover, her firm has extensive experience in…
Strategy and Sales Analysis for In Vitro Diagnostics and Biopharmaceuticals
Expert has multiple experiences in evaluating and proposing strategy for brands or individual products. This list includes several existing diagnostic products where lifecycle planning needs require judicious selection of new and novel add-ons to an existing line. It also includes…
VOIP, Data Communications (LAN/WAN), Telecommunications, PBX. Contracts and SLA Req.
Global Solutions Architect: Review and analyze current technology infrastructure and its ability to support strategic corporate objectives. Identify and propose specific strategies, initiatives and remedies necessary to align technology infrastructure with customer's corporate objectives. Support development of business drivers, business…