PHARMACEUTICAL SCIENCES CONSULTANCY AND OUTSOURCED MANUFACTURING OPERATIONS MANAGEMENT PharmaSci Consulting Limited supports global pharmaceutical and healthcare markets in the outsourced development and manufacture of pharmaceutical products. A broad knowledge to support your outsourced pharmaceutical development, technology transfer and commercial manufacturing requirements including: Formulation development Clinical supplies manufacture CMO identification and assessment Scale-up and technology transfer Process development and optimisation Process validation Design and coordination of ICH stability studies High quality development, manufacturing and regulatory documentation CMC documentation review Quality audits e.g. CMO, API, excipients, primary packaging components Contract Responsible Person New product due diligence for development and manufacturing facilities Third party manufacturing operations management Technical operations leadership Project management and coordination All dosage forms supported including • Immediate and modified release solid oral dosage forms e.g. tablets, capsules, multiparticulates, granules and powders • Oral solutions and suspensions • Sterile solutions and freeze dried powders • Topical liquids and gels • Specialised nasal products e.g. liquids, gelling solutions, gels and powders • Other drug delivery systems e.g. oral transmucosal and transdermal products
PHARMACEUTICAL SCIENCES CONSULTANCY AND OUTSOURCED MANUFACTURING OPERATIONS MANAGEMENT PharmaSci Consulting Limited supports global pharmaceutical and healthcare markets in the outsourced development and manufacture of pharmaceutical products. A broad knowledge to support your outsourced pharmaceutical development, technology transfer and commercial manufacturing requirements including: Formulation development Clinical supplies manufacture CMO identification and assessment Scale-up and technology transfer Process development and optimisation Process validation Design and coordination of ICH stability studies High quality development, manufacturing and regulatory documentation CMC documentation review Quality audits e.g. CMO, API, excipients, primary packaging components Contract Responsible Person New product due diligence for development and manufacturing facilities Third party manufacturing operations management Technical operations leadership Project management and coordination All dosage forms supported including • Immediate and modified release solid oral dosage forms e.g. tablets, capsules, multiparticulates, granules and powders • Oral solutions and suspensions • Sterile solutions and freeze dried powders • Topical liquids and gels • Specialised nasal products e.g. liquids, gelling solutions, gels and powders • Other drug delivery systems e.g. oral transmucosal and transdermal products