CSV, CSA & data-integrity consultants

Specialists whose sites describe computerised system validation (CSV), computer software assurance (CSA), 21 CFR Part 11 / EU Annex 11 compliance, GAMP 5 or data-integrity (ALCOA+) work.

71 profiles. Looking for a csv consultant? Read our neutral hire guide before you engage anyone.

Independent directory. Listings are compiled from information firms publish on their own websites and are not endorsements, rankings or verifications of credentials. All profiles are currently unclaimed.

Adryan

📍 Basel, Switzerland · Delivery mode not stated

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AHealth

📍 France · Delivery mode not stated

CSV/CSA & data integrity

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Apotech Consulting

📍 Not stated on website · Remote · On-site

GMP audits & mock inspections EU/UK Qualified Person (QP)CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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Arslan Quality Consulting

📍 San Diego, CA, USA · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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Assurea

📍 Not stated on website · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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B3 Quality (Bio Technology Consulting)

📍 Durham, NC, USA · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity QMS build-outs Supplier quality audits Clinical GCP auditing

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Bio Products Validation (BPV)

📍 United Kingdom · On-site

CSV/CSA & data integrity Sterile/aseptic & contamination control

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BioBoston Consulting

📍 Boston, MA, USA · Remote · On-site

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BioPharma Consulting Group

📍 Not stated on website · Delivery mode not stated

CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Sterile/aseptic & contamination control Supplier quality audits

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Bridgepoint

📍 Eau Claire, WI, USA · Remote

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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BushmanQC

📍 Not stated on website · Remote

CSV/CSA & data integrity QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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ChemPharm Consulting

📍 Singapore · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing

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CIRG (Mock FDA Inspection)

📍 Not stated on website · Remote · On-site

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ClemTech Medical Solutions

📍 Not stated on website · Delivery mode not stated

CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Medical device QMS (ISO 13485/QMSR)

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Compliance Architects

📍 Not stated on website · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation Supplier quality audits Clinical GCP auditing

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CPM

📍 Spain · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation Supplier quality audits

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Creative Quality Solutions

📍 Raleigh, NC, USA · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Clinical GCP auditing

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CSA Validation (CSA-QMS)

📍 Not stated on website · Delivery mode not stated

CSV/CSA & data integrity QMS build-outs Supplier quality audits

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CSVuk

📍 North West England, UK · On-site

GMP audits & mock inspections CSV/CSA & data integrity Supplier quality audits

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DGS Pharmaceutical Consultancy Ltd

📍 United Kingdom · On-site

GMP audits & mock inspections CSV/CSA & data integrity QMS build-outs Clinical GCP auditing

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Double Helix Pharma UK Ltd

📍 Aylesbury, UK · Remote · On-site

GMP audits & mock inspections EU/UK Qualified Person (QP)CSV/CSA & data integrity QMS build-outs Sterile/aseptic & contamination control Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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Entourage

📍 Not stated on website · Remote · On-site

GMP audits & mock inspections EU/UK Qualified Person (QP)CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Sterile/aseptic & contamination control Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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Eranova Pharma

📍 Spain · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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FD-AID

📍 Not stated on website · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation Sterile/aseptic & contamination control Supplier quality audits Clinical GCP auditing

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FDA Compliance Group

📍 Broomfield, CO, USA · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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GCP Clinical Trials

📍 Not stated on website · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity Supplier quality audits Clinical GCP auditing

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GMP Auditing & Consulting LLC

📍 Malvern, PA, USA · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Sterile/aseptic & contamination control Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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Grupo Asinfarma

📍 Spain · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity Sterile/aseptic & contamination control Supplier quality audits

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GS Consulting

📍 Rome, Italy · On-site

CSV/CSA & data integrity Supplier quality audits

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GxP Auditing and Consulting Services (GxPAuditConsult)

📍 Not stated on website · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Sterile/aseptic & contamination control Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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GxP Global Quality Network

📍 Wilmington, DE, USA · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing

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IncepBio

📍 Kuala Lumpur, Malaysia · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity QMS build-outs Sterile/aseptic & contamination control Supplier quality audits

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Inspectorate GMP Consulting (ICGMP)

📍 Not stated on website · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation

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Microrite Inc.

📍 San Jose, CA, USA · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation Sterile/aseptic & contamination control Supplier quality audits

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Ofni Systems

📍 Not stated on website · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation

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Option One Consulting (OOC)

📍 Switzerland · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity QMS build-outs Sterile/aseptic & contamination control Regulatory submissions (IND/BLA/NDA/MAA, CMC)Medical device QMS (ISO 13485/QMSR)

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Orion GXP Consulting

📍 Manchester, UK · Remote · On-site

GMP audits & mock inspections EU/UK Qualified Person (QP)CSV/CSA & data integrity QMS build-outs Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing

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Pharmaceutical Consultancy Services (PCS)

📍 Netherlands · Remote · On-site

GMP audits & mock inspections EU/UK Qualified Person (QP)CSV/CSA & data integrity QMS build-outs Sterile/aseptic & contamination control Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)

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Pharmaco Consulting International Ltd

📍 Not stated on website · Delivery mode not stated

CSV/CSA & data integrity Sterile/aseptic & contamination control

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PharmaCompliance.DK

📍 Denmark · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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PharmaQP

📍 Newcastle, UK · Remote · On-site

GMP audits & mock inspections EU/UK Qualified Person (QP)CSV/CSA & data integrity QMS build-outs Supplier quality audits

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PharmExpert Consultant LLP

📍 India · Remote · On-site

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PharmOut

📍 Australia · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Sterile/aseptic & contamination control Supplier quality audits Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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Prime GMP Solutions

📍 India · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity QMS build-outs Sterile/aseptic & contamination control Regulatory submissions (IND/BLA/NDA/MAA, CMC)

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Q-Exel GxP

📍 India · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits

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QMLogic

📍 Not stated on website · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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QMSAdvisor

📍 Not stated on website · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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QP Pro Services

📍 Belgium · Remote · On-site

GMP audits & mock inspections EU/UK Qualified Person (QP)CSV/CSA & data integrity QMS build-outs Sterile/aseptic & contamination control Supplier quality audits

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QPService

📍 Saalfeld, Germany · Delivery mode not stated

GMP audits & mock inspections EU/UK Qualified Person (QP)CSV/CSA & data integrity

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QRCC

📍 Hertfordshire / Cambridgeshire, UK · Remote

GMP audits & mock inspections CSV/CSA & data integrity QMS build-outs Supplier quality audits Clinical GCP auditing

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Qualirus Ltd

📍 Cork, Ireland · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity QMS build-outs Supplier quality audits

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Qualitice

📍 Not stated on website · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity Supplier quality audits

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QUALIVAL

📍 Les Ulis, France · On-site

CSV/CSA & data integrity

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QV-Compliance A/S

📍 Roskilde, Denmark · Delivery mode not stated

CSV/CSA & data integrity QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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QVAL Consulting

📍 Not stated on website · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Sterile/aseptic & contamination control Supplier quality audits

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QxP Pharma Project & GMP Services

📍 India · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation Sterile/aseptic & contamination control Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)

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Regulatory Leadership Partners

📍 Not stated on website · Remote

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Sharpnack Consulting

📍 Not stated on website · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation Sterile/aseptic & contamination control

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Simple Quality Systems LLC

📍 Philadelphia, PA, USA · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity QMS build-outs Supplier quality audits

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Sparsh Strategic Consulting

📍 Singapore · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity Supplier quality audits

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SQA Solution

📍 Daly City, CA, USA · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity Medical device QMS (ISO 13485/QMSR)

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Stingar

📍 Rome, Italy · Delivery mode not stated

GMP audits & mock inspections EU/UK Qualified Person (QP)CSV/CSA & data integrity Sterile/aseptic & contamination control

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Tailwind Pharma

📍 Not stated on website · Remote · On-site

GMP audits & mock inspections CSV/CSA & data integrity 483 & warning-letter remediation Sterile/aseptic & contamination control Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)

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The QARP

📍 Not stated on website · Remote

GMP audits & mock inspections CSV/CSA & data integrity QMS build-outs Supplier quality audits Clinical GCP auditing

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Toscano Consulting Group, Inc.

📍 Not stated on website · Delivery mode not stated

GMP audits & mock inspections EU/UK Qualified Person (QP)CSV/CSA & data integrity 483 & warning-letter remediation Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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tri-consulting

📍 Terrassa (Barcelona), Spain · Delivery mode not stated

CSV/CSA & data integrity Sterile/aseptic & contamination control Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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Truex Consultancy

📍 Netherlands · On-site

GMP audits & mock inspections EU/UK Qualified Person (QP)CSV/CSA & data integrity 483 & warning-letter remediation QMS build-outs Supplier quality audits

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Validated Systems

📍 Australia · Delivery mode not stated

CSV/CSA & data integrity

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ValSource Inc.

📍 Downingtown, PA, USA · On-site

GMP audits & mock inspections CSV/CSA & data integrity Sterile/aseptic & contamination control

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W2 Cleanroom Consulting

📍 United Kingdom · Delivery mode not stated

GMP audits & mock inspections CSV/CSA & data integrity QMS build-outs Sterile/aseptic & contamination control Supplier quality audits

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xFDA Investigators

📍 Not stated on website · Remote · On-site

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Other specialties

GMP audits & mock inspections EU/UK Qualified Person (QP)483 & warning-letter remediation QMS build-outs Sterile/aseptic & contamination control Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)