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Comprehensive CMC OutsourcingPharmaceutical CMC Consulting
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Pharmaceutical CMC Consulting
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Comprehensive CMC Outsourcing, LLC
Gaylen Zentner
6312 S. ●●●●●●●●n Circle
Salt ●●●●● City , Utah, 84121
United States
View this contact
Comprehensive CMC Outsourcing, LLC
Gaylen Zentner
6312 S. ●●●●●●●●n Circle
Salt ●●●●● City , Utah, 84121
United States
View this contact
Comprehensive CMC Outsourcing, LLC
Gaylen Zentner
6312 S. ●●●●●●●●n Circle
Salt ●●●●● City , Utah, 84121
United States
View this contact
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Pharmaceutical CMC Consulting
comprehensivecmc.com
Project Management
http://www.comprehensivecmc.com/project_management.html
Management and execution of all CMC activities (click "How it Works" tab) that support IND's, NDA's, clinical studies, and preclinical studies. Writing and defense of all CMC regulatory filings (including clinical protocols, investigator brochures, annual reports, etc.). Direction leading to identification and selection of appropriate chemical and physical forms of API's. Manage all aspects of contract API manufacturing in support of preclinical toxicology and preformulation/formulation studies. Manageme...
How it Works
http://www.comprehensivecmc.com/How_it_Works.html
8220;Changes of any kind in the API after clinical work has begun (Phase I) can. Trigger additional preclinical and clinical studies, including clinical hold.”. CCMCO provides the following, comprehensive services for the Drug Substance (API):. Physical state (polymorphs and particle size). Manufacturable (scalable all the way to commercial) and economical. Formulatable into practical, patient friendly and cost effective dosage forms. Issue RFP to Proven, Qualified Vendors (competitive bid). Design and e...
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Comprehensive CMC Outsourcing
http://www.comprehensivecmc.com/Home_Page.html
Comprehensive CMC Outsourcing, LLC. Is a single-source chemistry, manufacturing and controls (CMC) consulting and services group. The CCMCO Team offers clients a turn-key and comprehensive CMC function that is very cost effective and available on an as needed basis. Will provide all regulatory mandated documents, clinical supplies, and commercial manufacturing plans to support national/international studies and sales.
About Us
http://www.comprehensivecmc.com/About_Us.html
Gaylen M. Zentner. Principal Partner and Founder. 8212; All technical, manufacturing, and documentation aspects of Chemistry, Manufacturing and Control (CMC) sections of regulatory submissions; drug substance and drug product; sophisticated drug delivery systems, controlled release, solubilization, and bioavailability enhancement; human and veterinary drug development programs have been advanced through preclinical development and into clinical trials in the US, EU, and Asia; 33 years experience. 8212; M...
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Comprehensive CMC Outsourcing
Comprehensive CMC Outsourcing, LLC. Is a single-source chemistry, manufacturing and controls (CMC) consulting and services group. The CCMCO Team offers clients a turn-key and comprehensive CMC function that is very cost effective and available on an as needed basis. Will provide all regulatory mandated documents, clinical supplies, and commercial manufacturing plans to support national/international studies and sales.
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