Regulatory


• Feasibility study for selection of pharmaceutical products and herbal and dietary supplements
• Accomplishment and management of different projects, including:
   • CTD/DMF dossier preparation or review and filing for registration of pharmaceutical products and herbal and dietary supplements according to Ministry of Health and Medical Education (Deputy of Food and Drug authority) regulations
   • introduction of new molecules or new pharmaceutical dosage forms/strengths and documentation for Iran Drug List Entrance
   • document preparation for Insurance Drug List Entrance
   • document preparation including working instruction and SOPs for manufacturing, quality control, research & development, quality assurance, HSE, MSDS and PM
   • inspection & gap analysis
   • formulation correction and improvement

 

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