Quality management system (QMS) build-out consultants

Consultants describing quality management system (QMS / PQS) design, implementation or remediation – from phase-appropriate start-up systems to commercial-scale programmes.

82 profiles. Looking for a qms 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.

AaMEDI

📍 Switzerland · On-site

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Adryan

📍 Basel, Switzerland · Delivery mode not stated

CSV/CSA & data integrity QMS build-outs Sterile/aseptic & contamination control

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Aegisana

📍 Spain · On-site

GMP audits & mock inspections QMS build-outs Clinical GCP auditing

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Agata Porwol Compliance & Quality Consulting

📍 Germany · Remote · On-site

QMS build-outs Medical device QMS (ISO 13485/QMSR)

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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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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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Cell&Gene Consulting Inc.

📍 Not stated on website · Delivery mode not stated

QMS build-outs Regulatory submissions (IND/BLA/NDA/MAA, CMC)

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CeutiQus

📍 United Kingdom · On-site

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

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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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CHRQ Consulting, LLC

📍 Seattle area, WA, USA · Delivery mode not stated

QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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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-Science Ltd

📍 United Kingdom · Delivery mode not stated

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

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Copperhead QARA/RP Services Ltd

📍 United Kingdom · Delivery mode not stated

QMS build-outs Medical device QMS (ISO 13485/QMSR)

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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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DB GxP Quality Advisors

📍 Not stated on website · Delivery mode not stated

GMP audits & mock inspections QMS build-outs Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)

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Device Quality Ltd.

📍 Ireland · Remote · On-site

QMS build-outs Sterile/aseptic & contamination control Medical device QMS (ISO 13485/QMSR)

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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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EMMA International

📍 Miami, FL, USA · Delivery mode not stated

483 & warning-letter remediation QMS build-outs 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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FQS Pharma

📍 Belfast, UK / Ireland · Remote · On-site

GMP audits & mock inspections EU/UK Qualified Person (QP)QMS build-outs Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)

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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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GMP Bridge

📍 Not stated on website · Delivery mode not stated

GMP audits & mock inspections 483 & warning-letter remediation QMS build-outs Sterile/aseptic & contamination control 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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Helix Life Sciences AG

📍 Switzerland · Delivery mode not stated

QMS build-outs Regulatory submissions (IND/BLA/NDA/MAA, CMC)Medical device QMS (ISO 13485/QMSR)

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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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Isli Consulting

📍 Not stated on website · Remote · On-site

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

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JLM Pharma

📍 United Kingdom · Delivery mode not stated

GMP audits & mock inspections QMS build-outs Supplier quality audits

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Ken Block Consulting

📍 Richardson, TX, USA · Remote · On-site

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

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Limehill Quality Solutions

📍 Not stated on website · Remote

QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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M.P.C.A. International

📍 Belgium · Remote

GMP audits & mock inspections EU/UK Qualified Person (QP)QMS build-outs Regulatory submissions (IND/BLA/NDA/MAA, CMC)Medical device QMS (ISO 13485/QMSR)

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MD Compliance

📍 Glasgow, UK · Delivery mode not stated

QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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MDR Consultants

📍 Not stated on website · Delivery mode not stated

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

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MDRA

📍 Watford, UK · Delivery mode not stated

QMS build-outs Sterile/aseptic & contamination control Regulatory submissions (IND/BLA/NDA/MAA, CMC)Medical device QMS (ISO 13485/QMSR)

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Medical Device Academy

📍 Not stated on website · Remote · On-site

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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Medizinprodukte QM

📍 Moers, Germany · Delivery mode not stated

QMS build-outs Medical device QMS (ISO 13485/QMSR)

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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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Panacea Clinical Research

📍 Not stated on website · On-site

GMP audits & mock inspections 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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Pharma To Market

📍 Singapore / Malaysia · Delivery mode not stated

GMP audits & mock inspections QMS build-outs Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)

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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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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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PQC, Inc. (Pharmaceutical Quality Consulting)

📍 Not stated on website · Delivery mode not stated

GMP audits & mock inspections 483 & warning-letter remediation QMS build-outs Clinical GCP auditing

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Pragma GCP Consulting

📍 South Wales, UK · Delivery mode not stated

QMS build-outs Clinical GCP auditing

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Precision Regulatory Consulting LLC

📍 Not stated on website · Delivery mode not stated

QMS build-outs Regulatory submissions (IND/BLA/NDA/MAA, CMC)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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PRO Pharma Consulting

📍 Switzerland · On-site

QMS build-outs Supplier quality audits

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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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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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Qualomics

📍 Not stated on website · Remote · On-site

483 & warning-letter remediation QMS build-outs Supplier quality audits Medical device QMS (ISO 13485/QMSR)

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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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R2 Pharma Solutions

📍 Australia · Delivery mode not stated

GMP audits & mock inspections QMS build-outs Medical device QMS (ISO 13485/QMSR)

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RA Consultancy

📍 Belgium · Delivery mode not stated

GMP audits & mock inspections QMS build-outs 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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Rexpharma

📍 Ireland · Delivery mode not stated

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

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SA Quality Solutions (SAQMS)

📍 Not stated on website · Remote · On-site

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

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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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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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The Quality Consortium

📍 Ontario, Canada · Delivery mode not stated

QMS build-outs Supplier quality audits Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)

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Trautmann Managementsysteme

📍 Germany · Remote · On-site

GMP audits & mock inspections QMS build-outs 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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Vinayak Pharma Consultancy Limited (VPharma)

📍 Dublin, Ireland · Remote · On-site

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

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Virtual Quality Partners

📍 Ireland · Remote

GMP audits & mock inspections EU/UK Qualified Person (QP)QMS build-outs Regulatory submissions (IND/BLA/NDA/MAA, CMC)

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