Quality, GxP & Validation Vendors

Vendors supporting life sciences quality systems, GxP compliance, eQMS, audits, inspection readiness, CAPA, deviations, change control, document control, validation, data integrity, and regulated training.

Workflows in this category

Rook Quality Systems provides consulting and research services for medical device quality systems, regulatory strategy, clinical studies, and validation.
Evidence-backed workflow match
Matches Quality Management System (QMS) Consulting
“Rook Quality Systems helps companies design, implement, manage and optimize their QMS, streamlining compliance, automating critical tasks, and improving efficiency across the…”
Source: rookqs.com

Also offers: Quality Risk Management, Medical Device & IVD Regulatory Affairs

Clarkston Consulting is a life-sciences consulting firm providing quality compliance, digital and AI strategy, and transformation services.

Products: Cell Therapy Orchestration Platform (CTOP), Life Sciences Accelerator for S/4HANA

Evidence-backed workflow match
Matches Quality Management System (QMS) Consulting
“With Clarkston as your partner, we design and implement quality processes and systems that fit your organizational objectives – today and tomorrow.”
Source: clarkstonconsulting.com

Also offers: GxP Compliance Consulting, Transformation, Integration & Change Management, +1 more

ProductLife Group is a life sciences consulting and outsourcing group for regulatory affairs, pharmacovigilance, quality and validation, and market access.

Products: D.AI.M.I.

Evidence-backed workflow match
Matches Computer System Validation & CSA
“Computerised Systems Validation in all GxP areas (Management Systems, Production Control Systems and Laboratory Applications)”
Source: plglifesciences.com

Also offers: Equipment, Process & Cleaning Validation, Regulatory Development Strategy & Agency Interactions, +5 more

Tunnell Consulting is a life sciences consulting firm providing GxP compliance, regulatory strategy, and technology transfer support.
Evidence-backed workflow match
Matches Quality Management System (QMS) Consulting
“QUALITY MANAGEMENT SYSTEMS, including support for the design and development of an effective QMS, global QMS management, SOP authoring support, QMS optimization, root cause…”
Source: tunnellconsulting.com

Also offers: GxP Compliance Consulting, Technology Transfer, Process Characterization & PPQ, +1 more

Biopharma Institute provides self-paced GxP and workforce training with manager reporting and SCORM-compatible corporate LMS integration.

Products: DSPro, VALPro +1 more

Evidence-backed workflow match
Matches GxP Training & Compliance LMS
“Providing an extensive list of current, high-quality courses and professional certifications in good manufacturing practice (cGMP) for pharmaceutical and medical device personnel.”
Source: biopharmainstitute.com
Halloran Consulting Group is a life-sciences consulting firm providing regulatory strategy, dossier writing, GxP quality, and clinical trial management.
Evidence-backed workflow match
Matches GxP Compliance Consulting
“…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

ArisGlobal is a life sciences software company for drug safety, regulatory information, quality management and medical information.

Products: LifeSphere, NavaX +4 more

Evidence-backed workflow match
Matches Electronic Quality Management System (eQMS) Software
“Quality Management System, powered by NavaX, provides a modern, cloud solution that combines best practices in quality management with the power of AI-enabled workflows and…”
Source: arisglobal.com

Also offers: Safety Database Platforms, PV Automation & AI Case Intake, +2 more

Veristat is a specialty CRO providing biostatistics, clinical data management, and regulatory strategy and writing services.

Products: InStat, CoAuthor

Evidence-backed workflow match
Matches Quality Management System (QMS) Consulting
“Veristat develops and maintains comprehensive Quality Management Systems that meet global regulatory standards and withstand agency scrutiny.”
Source: veristat.com

Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more

Veeva Systems is a life-sciences software and data provider offering CRM, medical information, regulatory, and clinical operations platforms.

Products: Vault CRM, Veeva RIM +6 more

Evidence-backed workflow match
Matches Electronic Quality Management System (eQMS) Software
“QMS is a cloud based quality management system designed to manage life sciences-specific quality processes.”
Source: veeva.com

Also offers: Life Sciences CRM, Regulatory Information Management (RIM) Platforms, +4 more

IQVIA is a CRO and technology provider delivering clinical trials, real-world evidence, commercial intelligence and safety operations.

Products: IQVIA Vigilance Platform, SmartSolve +4 more

Evidence-backed workflow match
Matches Quality Management System (QMS) Consulting
“…Our medical device, IVD and digital health compliance consulting, advanced technologies, quality management and regulatory systems (QMS/RIM) and trusted data are tailored to your…”
Source: iqvia.com

Also offers: Full-Service Clinical Trial Execution (CRO Services), Real-World Data Platform, +6 more

StarFish Medical is a medical device CDMO providing device design, regulatory affairs, contract manufacturing, and cleanroom assembly services.

Products: ELLA, Pathfinder

Evidence-backed workflow match
Matches Quality Management System (QMS) Consulting
“…Our team provides direct support for QMS architecture, documentation, validation, and auditing — ensuring quality systems that enable innovation, efficient operations, and…”
Source: starfishmedical.com

Also offers: Medical Device Product Design & Engineering, Prototyping & Design for Manufacturing, +2 more

Altasciences is an early phase CRO and CDMO providing toxicology, IND-enabling studies, clinical pharmacology, bioanalysis, and drug manufacturing.

Products: Acceleration Platform

Also offers: Toxicology Studies, First-in-Human (Phase I) Clinical Pharmacology Support, +2 more

Lumanity is a life sciences consultancy for market access strategy, health economic modeling, brand positioning and scientific communications.

Products: Lumanity Illuminator, Evidence Illuminator +9 more

Evidence-backed workflow match
Matches Audit/Inspection Readiness & Response Services
“Inspection readiness and remediation: Ensuring your organization, vendors, and sites are prepared through all stages of development, preventing holds, information requests, and…”
Source: lumanity.com

Also offers: Market Access Strategy & Launch Planning, Brand Strategy & Positioning, +2 more

CluePoints provides clinical trial oversight software and consulting for risk detection, data quality, monitoring, coding, and inspection readiness.
Evidence-backed workflow match
Matches Audit/Inspection Readiness & Response Services
“CluePoints' clinical specialists bring decades of hands-on industry experience to every engagement, from Risk-Based Quality Management (RBQM) framework design and platform…”
Source: cluepoints.com

Also offers: Risk-Based & Centralized Trial Monitoring, Clinical Data Management

Favicon of DCN Dx

CDMO / CMO · +5 more types

DCN Dx is an IVD CDMO and CRO providing assay development, clinical trial operations, regulatory support, and manufacturing services.

Products: miniDxR, MICA-200C +1 more

Evidence-backed workflow match
Matches Quality Management System (QMS) Consulting
“Quality System Design Implementation of rigorous systems to ensure compliance and reliability.”
Source: dcndx.com

Also offers: IVD Assay Development, IVD Manufacturing & Scale-Up, +2 more

Althian Clinical Research is a boutique CRO supporting clinical trials, regulatory submissions, safety, data, and real-world studies in Mexico and LATAM.
Evidence-backed workflow match
Matches GxP Training & Compliance LMS
“Whether you are training site staff on GCP requirements, onboarding a sponsor team unfamiliar with COFEPRIS, or running a workshop on Mexican regulatory submissions, Althian…”
Source: althian.com

Also offers: Full-Service Clinical Trial Execution (CRO Services), Marketing Authorization & Lifecycle Submission Support, +3 more

Saama is a life-sciences software and services provider offering biostatistics, clinical data management, data integration and AI-enabled analytics.

Products: Smart Data Quality, Smart Medical Coding +7 more

Evidence-backed workflow match
Matches CAPA & Deviation Management
“Drafts investigation narratives cited to source records, grounded in evidence at every step.”
Source: saama.com

Also offers: Clinical Data Management, Data Integration, ETL & Interoperability, +1 more

Yourway is a clinical supply chain provider offering clinical packaging and labeling, GMP depot storage and distribution, and temperature-controlled shipping.
Evidence-backed workflow match
Matches QP Services & Batch Certification
“Batch Certification of Sterile & Non-sterile products”
Source: yourway.com

Also offers: Clinical Supply Depots & GMP Warehousing, Primary & Secondary Pharmaceutical Packaging, +3 more

Blue Matter Consulting is a strategic consulting firm providing launch readiness, portfolio strategy, market access, and medical affairs planning.

Products: Twine, Narralytix +1 more

Evidence-backed workflow match
Matches CAPA & Deviation Management
“…Corrective and preventive action (CAPA) development & monitoring”
Source: bluematterconsulting.com

Also offers: Product Launch Strategy & Readiness, Market Access Strategy & Launch Planning, +2 more