Regulatory submission & CMC consultants

Firms whose sites reference regulatory submissions such as IND, BLA, NDA, ANDA, MAA, CTA/IMPD, CTD/eCTD dossiers or CMC (Module 3) authoring.

40 profiles. Looking for a regulatory submissions 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.

Alacrita Consulting

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

Unclaimed profileClaim or remove this profile

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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BioBoston Consulting

📍 Boston, MA, USA · Remote · On-site

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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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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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CMC Regulatory Services, LLC

📍 Not stated on website · Delivery mode not stated

Regulatory submissions (IND/BLA/NDA/MAA, CMC)

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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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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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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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eXmoor Pharma

📍 Bristol, UK · On-site

EU/UK Qualified Person (QP)Sterile/aseptic & contamination control Regulatory submissions (IND/BLA/NDA/MAA, CMC)

Unclaimed profileClaim or remove this profile

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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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)

Unclaimed profileClaim or remove this profile

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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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)

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

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

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

PhaRA

📍 Belgium · On-site

Regulatory submissions (IND/BLA/NDA/MAA, CMC)

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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)

Unclaimed profileClaim or remove this profile

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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PharmExpert Consultant LLP

📍 India · Remote · On-site

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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)

Unclaimed profileClaim or remove this profile

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&R Canada

📍 Canada · Delivery mode not stated

Regulatory submissions (IND/BLA/NDA/MAA, CMC)

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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)

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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Suite Life Sciences Consulting, LLC

📍 Not stated on website · Delivery mode not stated

Regulatory submissions (IND/BLA/NDA/MAA, CMC)

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

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

Vora CMC Advisory

📍 Not stated on website · Delivery mode not stated

Regulatory submissions (IND/BLA/NDA/MAA, CMC)

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 483 & warning-letter remediation QMS build-outs Sterile/aseptic & contamination control Supplier quality audits Clinical GCP auditing Medical device QMS (ISO 13485/QMSR)