GxP Compliance, Quality Risk & Product Quality
Compare vendors for gxp compliance, quality risk & product quality within Quality, GxP & Validation, covering Quality Risk Management, Complaint Handling & Nonconformance Management, GxP Compliance Consulting, GMP Manufacturing Compliance Support….
Capabilities in this workflow
Vendors supporting this workflow
Consulting / Advisory Firm · +2 more types
“Rook will work with your company to develop a comprehensive risk management platform for products and processes, including the use of PHAs, FMEAs (process, use, design, and…”Source: rookqs.com
Also offers: Quality Management System (QMS) Consulting, Medical Device & IVD Regulatory Affairs
Consulting / Advisory Firm · +1 more type
“cGMP/ cGLP, cGCP Assessments including general cGMP inspection readiness, PAI readiness, facility and equipment design, PART 11 compliance as well as data integrity assessments…”Source: tunnellconsulting.com
Also offers: Technology Transfer, Process Characterization & PPQ, Quality Management System (QMS) Consulting, +1 more
Consulting / Advisory Firm · +1 more type
Products: Cell Therapy Orchestration Platform (CTOP), Life Sciences Accelerator for S/4HANA
“Clarkston Consulting provides quality and compliance consulting, combining practical experience and industry insights to create value.”Source: clarkstonconsulting.com
Also offers: Quality Management System (QMS) Consulting, Transformation, Integration & Change Management, +1 more
CRO / Research Services Provider · +2 more types
Products: InStat, CoAuthor
“Risk assessment and monitoring”Source: veristat.com
Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more
Service Provider · +2 more types
Products: D.AI.M.I.
“Quality Risk Management, GMP Reviews, Risk Analysis and definition of adaptation plans”Source: plglifesciences.com
Also offers: Regulatory Development Strategy & Agency Interactions, End-to-End Pharmacovigilance Outsourcing, +6 more
Consulting / Advisory Firm · +2 more types
“…Halloran's approach involves a comprehensive assessment to design a tailored, GxP-compliant QMS aligned with your organization's size, stage of development, and business model…”Source: hallorancg.com
Also offers: Regulatory Development Strategy & Agency Interactions, Clinical Trial Project Management, +1 more
CRO / Research Services Provider · +7 more types
Products: IQVIA Vigilance Platform, SmartSolve +4 more
“Outsourced Complaint & Adverse Event Reports (AER)”Source: iqvia.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), Real-World Data Platform, +6 more
Software / Technology Platform · +2 more types
Products: Vault CRM, Veeva RIM +6 more
“Improve risk visibility across products and processes with a unified approach to risk management.”Source: veeva.com
Also offers: Life Sciences CRM, Regulatory Information Management (RIM) Platforms, +4 more
Consulting / Advisory Firm · +4 more types
Products: Lumanity Illuminator, Evidence Illuminator +9 more
“We bring operational quality and compliance rigor that keeps your programs inspection-ready and moving forward.”Source: lumanity.com
Also offers: Market Access Strategy & Launch Planning, Brand Strategy & Positioning, +2 more
Products: LifeSphere, NavaX +4 more
“Support the full product complaint process with clear, traceable workflows across intake, data validation, classification and assessment.”Source: arisglobal.com
Also offers: Safety Database Platforms, PV Automation & AI Case Intake, +3 more
CDMO / CMO · +3 more types
Products: ELLA, Pathfinder
“StarFish helps clients develop and execute strong verification, validation, and risk management practices that meet global regulatory expectations.”Source: starfishmedical.com
Also offers: Medical Device Product Design & Engineering, Prototyping & Design for Manufacturing, +2 more
“Batch Certification of Sterile & Non-sterile products”Source: yourway.com
Also offers: Clinical Supply Depots & GMP Warehousing, Primary & Secondary Pharmaceutical Packaging, +3 more
Software / Technology Platform · +2 more types
“Our RBQM experts analyze all clinical and operational data to identify sites at risk of inspection, empowering you to prepare for and mitigate potential issues before regulators…”Source: cluepoints.com
Also offers: Risk-Based & Centralized Trial Monitoring, Clinical Data Management
CDMO / CMO · +5 more types
Products: miniDxR, MICA-200C +1 more
“Risk Management Comprehensive strategies to mitigate development and manufacturing risks.”Source: dcndx.com
Also offers: IVD Assay Development, IVD Manufacturing & Scale-Up, +2 more