BioMed Nexus Industry Directory

Regulatory & Compliance
Consultants

The definitive directory of regulatory affairs consultancies, GxP compliance firms, pharmacovigilance specialists, and quality systems advisors serving the biotech and pharma industry. Curated for regulatory affairs teams preparing FDA submissions, quality leaders building GxP programs, and biotech executives navigating global compliance.

145
Firms Listed
7
Categories
$12B
Reg Affairs Consulting (2030)
100,000 Directory Views
65,000+ Newsletter Subscribers
1.1M Monthly Impressions
Distributed via the BioMed Nexus Daily Brief
Directory Regulatory & Compliance Consultants

BioMed Nexus tracks 145 regulatory and compliance consultancies across 7 categories: regulatory strategy & FDA, GxP & GMP compliance, pharmacovigilance & safety, CMC & manufacturing, quality systems & auditing, global/EU/APAC, and Big 4 management consulting. The directory covers leading firms including ProPharma Group, PharmaLex, Lachman Consultants, NSF, Certara and Parexel, alongside specialist boutiques. Last updated July 2026

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All Listed Firms / 145 firms

Firm Database
Regulatory Compliance Associates (RCA)Upgrade listing →
PAREXEL (Regulatory)Upgrade listing →
Covance/Labcorp (Regulatory)Upgrade listing →
Greenleaf HealthUpgrade listing →
Camargo Pharmaceutical ServicesUpgrade listing →
Regulatory Resources GroupUpgrade listing →
Premier ConsultingUpgrade listing →
Biologics ConsultingUpgrade listing →
Cato Research (Regulatory)Upgrade listing →
Cardinal Health Regulatory SciencesUpgrade listing →
Regulatory Affairs AssociatesUpgrade listing →
Pacific Bridge MedicalUpgrade listing →
CDER SolutionsUpgrade listing →
Veristat (Regulatory)Upgrade listing →
Criterium (Regulatory)Upgrade listing →
CAI (Commissioning Agents)Upgrade listing →
Jacobs Engineering (Life Sci)Upgrade listing →
IPS (Integrated Project Services)Upgrade listing →
NNE (Novo Nordisk Engineering)Upgrade listing →
GxP LifescienceUpgrade listing →
Ellab (Validation)Upgrade listing →
Kneat SolutionsUpgrade listing →
QualityOne InternationalUpgrade listing →
Sterling Pharma Solutions (QA)Upgrade listing →
Porzio Life SciencesUpgrade listing →
Compliance InsightUpgrade listing →
IQVIA (PV Services)Upgrade listing →
Accenture (Life Sciences PV)Upgrade listing →
Cognizant (PV)Upgrade listing →
TCS (PV Services)Upgrade listing →
Infosys (Life Sciences PV)Upgrade listing →
DrugDev (IQVIA)Upgrade listing →
Oracle Argus (Safety)Upgrade listing →
Mdsol (Safety)Upgrade listing →
Sarjen SystemsUpgrade listing →
United BioSource (UBC)Upgrade listing →
Advera Health AnalyticsUpgrade listing →
Lachman (CMC)Upgrade listing →
Rho (CMC Consulting)Upgrade listing →
Regulus RegulatoryUpgrade listing →
CMC Consulting GroupUpgrade listing →
Lonza (Regulatory)Upgrade listing →
Catalent (Regulatory)Upgrade listing →
SGS (Life Sciences)Upgrade listing →
Eurofins (Regulatory)Upgrade listing →
Charles River (Regulatory)Upgrade listing →
WuXi (Regulatory)Upgrade listing →
Piramal (Regulatory)Upgrade listing →
Alcami (Regulatory)Upgrade listing →
KBI Biopharma (CMC)Upgrade listing →
BioReliance (Merck)Upgrade listing →
Bureau Veritas (Life Sciences)Upgrade listing →
BSI Group (Medical)Upgrade listing →
TÜV SÜD (Life Sciences)Upgrade listing →
Intertek (Pharma)Upgrade listing →
UL Solutions (Healthcare)Upgrade listing →
PDA (Parenteral Drug Assoc)Upgrade listing →
DIA (Drug Information Assoc)Upgrade listing →
ASQ (Healthcare)Upgrade listing →
EMMA InternationalUpgrade listing →
Tunnell ConsultingUpgrade listing →
Compliance Solutions GroupUpgrade listing →
Pharma Intelligence (Citeline)Upgrade listing →
NDA Regulatory ScienceUpgrade listing →
Novaquest (EU)Upgrade listing →
CIRS (Centre for Innovation)Upgrade listing →
Shire Regulatory (EU)Upgrade listing →
Emergo by UL (Global)Upgrade listing →
Freyr SolutionsUpgrade listing →
Navitas Life SciencesUpgrade listing →
Lupin Regulatory (APAC)Upgrade listing →
Pharmaceutical Consultants JapanUpgrade listing →
APAC Regulatory NetworkUpgrade listing →
Novatek InternationalUpgrade listing →
Tata Consultancy (LS Reg)Upgrade listing →
Deloitte (Life Sciences)Upgrade listing →
KPMG (Life Sciences)Upgrade listing →
EY (Life Sciences)Upgrade listing →
PwC (Pharma & Life Sciences)Upgrade listing →
McKinsey (Pharma)Upgrade listing →
BCG (Health Care)Upgrade listing →
Bain (Healthcare)Upgrade listing →
L.E.K. Consulting (Life Sci)Upgrade listing →
Simon-Kucher (Pharma)Upgrade listing →
ZS AssociatesUpgrade listing →
Putnam AssociatesUpgrade listing →
ClearView HealthcareUpgrade listing →
Trinity Life SciencesUpgrade listing →
Health AdvancesUpgrade listing →
Charles River AssociatesUpgrade listing →
Analysis Group (Life Sci)Upgrade listing →
Precision Medicine GroupUpgrade listing →
IQVIA (Consulting)Upgrade listing →
ProPharma GroupUpgrade listing →
Lachman ConsultantsUpgrade listing →
Halloran ConsultingUpgrade listing →
NSF Health SciencesUpgrade listing →
BioBoston ConsultingUpgrade listing →
Syneos Health (Regulatory)Upgrade listing →
ELIQUENT Life SciencesUpgrade listing →
Opus RegulatoryUpgrade listing →
Fortrea (Labcorp)Upgrade listing →
Excellis HealthUpgrade listing →
Kinapse (Syneos)Upgrade listing →
Cencora (CMC/Regulatory)Upgrade listing →
Voisin Consulting (VCLS)Upgrade listing →
ProductLife GroupUpgrade listing →
Real RegulatoryUpgrade listing →
Capgemini (Life Sciences)Upgrade listing →
Guidehouse (Life Sciences)Upgrade listing →

Regulatory & Compliance Consultants: Frequently Asked Questions

How many regulatory consulting firms are in this directory?
This directory lists 145 regulatory affairs and compliance consultancies across seven categories: regulatory strategy and FDA, GxP and GMP compliance, pharmacovigilance and safety, CMC and manufacturing, quality systems and auditing, global/EU/APAC, and Big 4 management consulting. It is updated regularly by the BioMed Nexus editorial team.
Who are the top regulatory affairs consulting firms in 2026?
Leading regulatory affairs consultancies include ProPharma Group, PharmaLex, Lachman Consultants, Parexel, NSF, Certara, ELIQUENT and Halloran Consulting. They support FDA and EMA strategy, submissions, GxP compliance and pharmacovigilance for pharma, biotech and medical devices.
What does a regulatory and compliance consultant do?
Regulatory and compliance consultants help life sciences companies plan regulatory strategy, prepare IND, NDA, BLA and MAA submissions, build GxP and quality systems, run pharmacovigilance, prepare for FDA and EMA inspections, and remediate warning letters. Many are staffed by former FDA and EMA officials.
What is GxP compliance?
GxP refers to 'good practice' quality regulations, including GMP (manufacturing), GLP (laboratory), GCP (clinical) and GDP (distribution). GxP compliance consultancies help manufacturers meet FDA and EMA standards through audits, gap assessments, validation and inspection readiness. Examples include NSF, FDAQRC, Azzur Group and PSC Biotech.
Which firms handle pharmacovigilance and drug safety?
Firms known for pharmacovigilance and drug safety include Certara, IQVIA, ICON, ProPharma, Genpact and Sciformix. Services span case processing, signal detection, aggregate reporting, QPPV support and safety database management under FDA and EMA requirements.
How can a consulting firm get listed or featured in the directory?
Any regulatory or compliance consulting firm can claim a free basic listing. Featured Partners receive priority placement at the top of the directory, a dedicated landing page, backlinks, and a featured segment in the BioMed Nexus daily newsletter reaching 65,000+ subscribers. Spots are limited, so contact the BioMed Nexus partnerships team to learn more.
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Right now, every firm in this directory is just a name in a database. Featured partners get a full profile with logo, service areas, regulatory expertise, backlinks, and priority placement at the very top of this page, seen by 65,000+ biotech professionals every week. Claim the top spot before your competitors do.

About the Regulatory & Compliance Consultants Directory

The BioMed Nexus Regulatory & Compliance Consultants Directory is a comprehensive, regularly updated list of regulatory affairs consultancies, GxP and GMP compliance firms, pharmacovigilance and drug safety providers, CMC and manufacturing regulatory experts, quality systems and auditing firms, global and regional regulatory specialists, and life sciences management consulting practices serving the biotech, pharma and medical device industry.

Use it to research regulatory consultants by specialty, shortlist partners for FDA and EMA submissions, and compare boutique regulatory firms against global consultancies. Whether you are a regulatory affairs team preparing an IND or NDA, a quality leader building inspection readiness, or a biotech executive navigating global regulatory pathways, the directory provides structured, current firm data. Curated and maintained by the BioMed Nexus editorial team; last updated July 2026.

Firms can claim a free basic listing or become a Featured Partner for priority placement, a dedicated landing page, backlinks, and a featured segment in the BioMed Nexus daily newsletter reaching 65,000+ subscribers. Contact our partnerships team to learn more.

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