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Medical Devices, Pharmaceuticals, CMC, Regulatory Affairs, R&D, Design Controls, Autoinjectors, Syringes, and Manufacturing
Expert has extensive experience in Pharmaceutical and Medical Device industry. He managed multiple departments and spearheaded combination product activities to launch products. This included FDA/EMA meetings, Human Factor activities, Device Design and Development, Regulatory submissions, and Manufacturing responsibilities. He has…
TVET and Education
Expert has global experience delivering TVET projects and creating solutions designed to align labour market skills needs to economic and education reforms. Strong focus on practical skills acquisition and employability pathways. Expert has more than 25 years of experience in…
Pharmaceutical Formulation, Process Development and Manufacturing of Products Focusing on Poorly Water Soluble Drugs
Extensive experience in formulation design and manufacturing process development and optimization gained working for large, medium and smaller companies.Having worked on the development of a relatively large number of small molecules at all stages of development, Expert has gained specialist…
Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices
Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…
Food Science
Expert is a Food Scientist with extensive and diversified experience in multiple food technologies and product types working for global food companies. He is a recognized expert in commercial product launches, technology implementation, factory optimizations and start-ups, cost reductions, and…
Polymers, Plastics, Composites, Plastic Pipe, Composite Pipe, and Failure Analysis
Throughout his 41-plus-year career experience in the plastics industry, Expert has worked in research and development, product development, technical services, application development, failure analysis, sales, marketing, market development, business development, R&D management, small business unit management, trade association management and…
Wetlands, Wildlife, Storm Water, Erosion Control, Hydroponics, Aquaculture: Program and Project Management
Expert has a broad and comprehensive grasp of biological and ecological sciences. He specializes in land and water management. For land management, the services provided may range from aquaculture and hydroponic operations to environmental compliance operations. For water management, it…
Quality Assurance, Regulatory Affairs, and New Product Development Consultant
BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…
Good Clinical Practice (GCP), clinical trials, regulatory authority inspections, audits, QM
Expert is a former GCP inspector with the German Federal Institute for Drugs and Medical Devices [BfArM]. She has led and conducted GCP inspections on behalf of EMA and national authorities all over the world. Expert has experience in assessing…
Australian & New Zealand Food Regualtory Affairs, Food Toxicology, Novel foods, Health Claims.
Expert specializes in the provision of consultancy services in food regulatory affairs and development of compliance systems. Clients include both large and small food manufacturers, industry associations and government agencies. The consultancy he works for provides a comprehensive range of…