GMP audit consultants & mock-inspection specialists

Independent auditors and small firms whose own websites describe GMP/GxP audits, gap assessments, inspection-readiness programmes or mock regulatory inspections (FDA, EMA, MHRA and others).

91 profiles. Looking for a gmp audit 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.

Aegisana

📍 Spain · On-site

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Alacrita Consulting

📍 London, UK / Cambridge, MA, USA · On-site

GMP audits & mock inspections Supplier quality audits Regulatory submissions (IND/BLA/NDA/MAA, CMC)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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Aseptic Processing Consult

📍 Not stated on website · Delivery mode not stated

GMP audits & mock inspections Sterile/aseptic & contamination control

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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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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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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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CIRCLE Pharma Consulting

📍 France · Delivery mode not stated

GMP audits & mock inspections

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CIRG (Mock FDA Inspection)

📍 Not stated on website · Remote · On-site

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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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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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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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CSVuk

📍 North West England, UK · On-site

GMP audits & mock inspections CSV/CSA & data integrity 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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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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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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Gapp Quality GmbH

📍 Brixlegg, Tyrol, Austria · Delivery mode not stated

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

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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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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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GMP Pharma Service GmbH

📍 Germany · Delivery mode not stated

GMP audits & mock inspections

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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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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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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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KeyQP Pharma

📍 Slough, UK · Delivery mode not stated

GMP audits & mock inspections EU/UK Qualified Person (QP)

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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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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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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)

Unclaimed profileClaim or remove this profile

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 Quality Management

📍 Sweden · Delivery mode not stated

GMP audits & mock inspections Clinical GCP auditing

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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)

Unclaimed profileClaim or remove this profile

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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Pharmalane UK

📍 London, UK · Delivery mode not stated

GMP audits & mock inspections Supplier quality audits Clinical GCP auditing 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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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)

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

R2 Pharma Solutions

📍 Australia · Delivery mode not stated

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

Unclaimed profileClaim or remove this profile

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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Regulatory Solutions Inc.

📍 Canada · Delivery mode not stated

GMP audits & mock inspections

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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

Unclaimed profileClaim or remove this profile

RQM GMP Consulting

📍 Buchs (SG), Switzerland · Delivery mode not stated

GMP audits & mock inspections EU/UK Qualified Person (QP)Supplier quality audits

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

Simple Quality Systems LLC

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

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

Unclaimed profileClaim or remove this profile

Sopharm s.a.s.

📍 Italy · Delivery mode not stated

GMP audits & mock inspections Sterile/aseptic & contamination control Supplier quality audits

Unclaimed profileClaim or remove this profile

Sparsh Strategic Consulting

📍 Singapore · Delivery mode not stated

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

Unclaimed profileClaim or remove this profile

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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Steed MicroBio

📍 Not stated on website · Delivery mode not stated

GMP audits & mock inspections Sterile/aseptic & contamination control

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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

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

ValSource Inc.

📍 Downingtown, PA, USA · On-site

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

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

Virtual Quality Partners

📍 Ireland · Remote

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

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

xFDA Investigators

📍 Not stated on website · Remote · On-site

Unclaimed profileClaim or remove this profile

Other specialties

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)