Jawanda Consulting

Consulting Services to scope, staff, manage and deliver GxP solutions across North America, Europe and the Asia-Pacific. Experience meeting business-critical GxP needs for our partners, our network of technical experts will work with you to scope your requirements, identify key risks and opportunities, and agree on milestones for successful delivery. We believe that every challenge is unique, which is why we adopt a tailor-made solution for each engagement; creating a roadmap for delivery that is purpose-built to your specific needs. Jawanda Consulting meets all requirements in-house, eliminating complex supply chains and increasing value. 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