Phlexglobal is the Trial Master File (TMF) Expert and pioneer in providing innovative, flexible, and technology-enabled TMF solutions & services.I help manage fast pace and chaotic issue resolution that boost quality, profitability, compliance, and efficiency – focusing on supporting services often combined with digital transformation in life-changing, and sometimes lifesaving, Life Sciences Companies.

ComplianceQuest is a highly flexible, 100% cloud-based EQMS built using the Salesforce platform. We streamline quality, compliance, content and collaboration management workflows across your company and globally-based supply chain networks, using the world's most proven enterprise cloud platform from Salesforce.

Navigator Business Solutions Helps Your Small-Midsize Business Run Like Never Before.Delivering SAP solutions exclusively to small-midsize businesses, including SAP Business One, SAP Business ByDesign and SAP Business One. Having successfully implemented more than 500 SAP solutions, Navigator has the experience, the insight, and the product offerings to make your best-run business RUN BETTER. From financials, sales & service to purchasing, inventory, and operations, SAP is the ultimate tool to completely run your small-midsize business. Every SAP solution is a single integrated real-time application designed to streamline operations, improve efficiency, and drive overall growth.

Experienced in market development, negotiation, and closing of top tier enterprise level accounts. Skill selling into ‘C’ level executives in both private and government sectors. Practiced in identifying new market opportunities, partner relations, and building satellite offices to grow business. Expert in competition displacement. Successful US Government Authority to Operate (ATO), FISMA and FedRAMP implementations. Compliance experience within validated environments of FDA 21CFR, ISO, GMP, QSR, MDSAP, EU MDR, UDI, CLIA, CAP and other compliance standards. Industry knowledge in Life Sciences to include Quality Management Systems (QMS) [and touch-points into Enterprise Resource Planning (ERP), Product Lifecycle Management (PLM), Manufacturing Execution System (MES)], Regulatory Management Information Systems (RIMS) [to include 510(k) and eCTD], Healthcare, Clinical [to include TMF and Quality], Manufacturing [to include Lean, eBR and eDHR] and Government Agencies. Expert consultation and strategic planning abilities. Strong aptitude to interlink successfully with cross functional business units within an organization and partner relationships. Ability to successfully organize, prioritize and manage multiple projects in a self-driven environment. Ability to successfully motivate and lead others in the definition, direction and execution of project initiatives. Successful in developing effective advertising and marketing strategies. Excellent prioritization skills developed through managing simultaneous projects in a fast-paced environment. Extremely positive, highly motivated, organized, and energetic, with excellent relationship building skills.