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Construction Safety
Expert has over 40 years' experience in worldwide professional safety. His work experience includes tenure as Corporate Safety and Security Director for four Engineering, Design and Construction Management Firms. This work has involved over 600 worldwide construction projects. Additionally, as…
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…
Parenteral/Sterile Product Formulation Development; Protein Peptide Formulation; Drug Delivery
Former Director, Formulation Research, Hoffmann-La Roche Inc.- primarily parenteral formulation and drug delivery systems – Extensive experience in the areas of formulation, drug delivery and clinical manufacturing - Member of Global Formulation Research Leadership Team – Four successfully launched peptide/protein…
Pharmaceutical Manufacture and Supply in Startup New Product Companies & Acquisition Integration
Expert has successfully developed and led a diversity of complex operations and projects in a variety of cultures and environments. These range from turnarounds and startups of flagship greenfield operations to cross functional teams in world-wide new product launches, and…
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…
Satellite, Space, and Launch Systems, Defense & Intel Market, Defense Budget, Business Development
Owner and CEO of Employer, a small firm focused on helping large and small aerospace companies develop new business, execute existing satellite and launch programs, and position themselves competitively for significant future growth. A specific focus on helping new commercial…
Corrosion, Microbiologically Influenced Corrosion Pipelines, Oil and Gas
Expert has been active in corrosion of oil and gas operations, pipelines, fire sprinkler systems and barges for over 25 years. His specialty is Microbiologically Influenced Corrosion (MIC) and has patented several formulations for coatings and MIC sampling devices. Corrosion…
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: •…
Regulatory Affairs/Registration Consultancy for Medical Devices/Drugs/IVDs/Food in Indian Market
Expert with a post graduate degree in Chemistry has been part of the team in the CDSCO, Government of India for framing of the Import Registration requirements for Drugs, Medical Devices and IVDs. Expert was the Medical Devices Reviewer for…
FDA, FTC, regulatory, fraud and abuse, e-discovery, OTC, pharma, sunshine act, social media
Expert currently serves as Regulatory Counsel for Allergan, providing proactive legal support to senior management, product brand teams, and client groups across organization, advising and educating on regulations pertaining to pharmaceutical products. He serves on multiple brand advertising and promotional…