Product Development, Delivery System & Clinical Trials
Growing, Manufacturing & Lab Facilities Design
Conceptual & detailed design including personnel/material flow diagram, pressure cascade, cleanness level, utilities and technology based on current GxP standards and common practices
Quality Assurance & Good Practices (GxP)
An effective quality management system establishment, policies and SOPs writing, cultivation and manufacturing procedures, protocols and employees training
Cultivation & Product Manufacturing Technology
Utilities, systems, machinery and controls required for cultivation, development and manufacturing processes that will enable high quality, control and cost-effectiveness.
New Product Regulations & Submissions
Cannabis products specifications and regulatory requirements completion including all relevant documentation and data in order to be submitted and sold in regulatory markets
Qualification &Validation
New facility, infrastructure, utilities, system, machinery, software, control system, manufacturing/cleaning processes qualification and validation protocols, execution and reports
Cosmetics product registration and submission in Israel
Guidelines for the process of cosmetics registration/submission in Israel The Department that is responsible to assure the safety and [...]
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Risk Assessment and Risk Management in the Medical and Pharmaceutical IndustriesRisk Assessment and Risk Management in the Medical and Pharmaceutical Industries
Articles, Medical Device, Medical Device, Phama/BioTech, Phama/BioTech articles, איכות ו-GxP, אמ”ר, ולידציה והסמכות, מצוינות תפעולית, פארמה וביוטק
Risk Assessment and Risk Management in the Medical and Pharmaceutical Industries
The medical and pharmaceutical industries are involved in new product development and manufacturing of medicines, medicinal products, biological products, [...]
Fermentation in the biopharmaceutical industry
1. Background Many biopharmaceutical and biological products are based on (different) cell-type fermentation. Biopharmaceutical products can be either intracellular [...]
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