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Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence
I have been involved in transdermal product development for 15 years and have spearheaded the development of quality control, quality assurance, regulatory affairs and clinical research departments. Among my activities are: 1. Designing preclinical, clinical and bioequivalence studies. 2. Filing…
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…
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…
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…
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: •…
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…
QC/QA, Sterility Assurance, Aseptic, Pharmaceutical, Biotech, Device Manufacturing & Testing
Environmental Monitoring Operations, EM Trends Reports, EM Remediation and Investigation. Cleanroom Contamination Control Practices, Behaviors, Personnel, Gowning, Cleanroom Traffic Guidelines, Process/Personnel and Product Flows. Microbiology Release Testing-Bioburden, Sterility Test, Growth Promotion, Materials Control, Microbial Identification, Bacteria Endotoxin, Biological Indicators Testing,…
Information Systems Audit & IT Assurance, System Controls & IT Security, Revenue Assurance & Value for Money Audit, Forensic & e-Fraud Investigation
Expert is a Certified Information System Auditor (CISA) with over 10 years of practical experience in Information Systems Audit, Information Systems control, Information Security Management System (ISMS), IT Security, IT Governance & Risk Management. He has an excellent background in…
Marine Ports and Terminals: Design, Processes, Technology, Optimisation
Hands-on management consultancy for Ports and Terminals: 1. Feasibility studies, business plans, cost and revenue studies. 2. Design: layout, processes, IT and Technology (Gate Systems, Position Detection systems, RFID), Equipment, organisational structure. 3. Procurement: Terminal Operating Systems, Port Community systems,…
Occupational Health and Safety
Expert is the owner and principal consultant at HighPoint Safety LTD. Expert is a Certified Health and Safety Consultant (CHSC) with over 30 years of workplace experience in a wide range of industries from retail to heavy construction He provides…