Whether your project is large or small, our team of experts can mobilize quickly, provide the resources, provide the solutions, and generate the deliverables you need to get the job done right. On time the first time! The Spillum & Associates, LLC track record for top talent, experienced consultants, and subject matter experts (SME) can simplify complex projects, overcome challenging obstacles, and help your organization achieve its objectives! Services Offered - Working with Contract Manufacturing Organizations (CMO / CDMO) - Technical Transfer / Site Transfer programs - Due Diligence Efforts / Audits - let the industry experts assess the CMO, facility, supplier, or partner - Project / Program Management - PMO, processes, systems, tools, & training - FDA Enforcement - FDA483, Warning Letter, Untitled Letter - Remediation Efforts - Consent Decree, Warning Letter, FDA483 Observations - Quality Management - including Quality Systems, processes, & procedures - Quality Culture - assessment, training & delivery of a QMS to meet regulatory requirements while working within your organizational needs - Gap Analysis / Risk Management - assessment initiatives vs. industry standard & industry excellence - Operations Management - SCI, CI, PI, Six Sigma, Development, Commercial