FDA 483 & warning-letter remediation consultants

Firms that state on their own websites that they support responses to FDA Form 483 observations, warning letters or consent decrees, including CAPA planning and remediation execution.

45 profiles. Looking for a warning letter remediation 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.

Apotech Consulting

📍 Not stated on website · Remote · On-site

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

CIRG (Mock FDA Inspection)

📍 Not stated on website · Remote · On-site

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

CPM

📍 Spain · On-site

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

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

EMMA International

📍 Miami, FL, USA · Delivery mode not stated

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

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

Inspectorate GMP Consulting (ICGMP)

📍 Not stated on website · On-site

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

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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

Unclaimed profileClaim or remove this profile

Ofni Systems

📍 Not stated on website · On-site

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

Unclaimed profileClaim or remove this profile

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)

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)

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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

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

Unclaimed profileClaim or remove this profile

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)

Unclaimed profileClaim or remove this profile

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

Qualomics

📍 Not stated on website · Remote · On-site

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

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

Regulatory Leadership Partners

📍 Not stated on website · Remote

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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)

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

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)

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

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

xFDA Investigators

📍 Not stated on website · Remote · On-site

Unclaimed profileClaim or remove this profile

Other specialties

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)Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)