Gaylen M. Zentner
Founder & Managing Partner @Comprehensive Cmc Outsourcing
Salt Lake City, UT, US
EMAILS
g••••••••@comprehensivecmc.com
MOBILE NUMBERS
+18•••••••94
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WORK HISTORY
Apr 2012 — Present
Founder & Managing Partner @Comprehensive Cmc Outsourcing
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Salt Lake City, UT, US
Consultant to the pharmaceutical industry. Expertise in chemistry, manufacturing, and controls (CMC) to support preclinical and clinical development. Expertise in controlled release drug delivery and novel formulations, including oral and injectable administration routes.
EDUCATION
N/A
University of Utah
PhD
SKILLS
Osmotic Pumps and Swelling PolymersInteractions with Regulatory Agencies (Fda, Mhra, Emea, Etc)Technology Evaluation and Diligence SupportDosage Form Design and ManufactureCommercial Launch Planning and ImplementationDrug Product Formulation, Characterization, and ManufactureImplantsClinical DistributionPharmaceutical IndustryFdaValidationGmpPh.1 - Ph.3 Clinical StudiesCROPharmaceuticsGlpFormulationBioavailability Enhancement & ModificationChange ControlTechnical Writing & Technical PresentationsLaboratoryDrug DevelopmentBiopharmaceuticalsAmorphous Solid Dosage FormsThird Party Logistics (3pl)Multinational Manufacturing PlanningDrug Substance & Drug Product Manufacturing Scale-UpBiotechnologyGmp & Glp ComplianceProject ManagementR&DSterile Parenteral Dosage FormsSolid Oral Dosage FormsClinical DevelopmentTechnology TransferRegulatory Submissions, Cmc SectionsStability Studies & TestingChemistryDrug DeliveryBiodegradable Polymers
ABOUT GAYLEN M. ZENTNER
Founder & Principal Partner at Comprehensive CMC Outsourcing
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