GlobalCompliance Solutions
GlobalCompliance Solutions Inc.
★★★★★
4.8
/ 5
•
127 reviews
Leading global regulatory compliance consultancy serving medical device manufacturers worldwide with comprehensive regulatory services.
About
**Who they are**
GlobalCompliance Solutions is a premier regulatory affairs consultancy with over 25 years of experience helping medical device manufacturers navigate complex global regulatory landscapes. Founded in 1999, we have established ourselves as trusted partners for companies ranging from startups to Fortune 500 enterprises.
**Expertise & scope**
Our comprehensive service portfolio covers all aspects of medical device regulatory compliance, including:
* **EU Authorized Representative Services**: Full MDR and IVDR compliance support for European market access
* **UK Responsible Person Services**: MHRA registration and ongoing regulatory support
* **FDA U.S. Agent Services**: Complete FDA registration, 510(k) submissions, and QSR compliance
* **PRRC Services**: Qualified Person Responsible for Regulatory Compliance as a service
* **EUDAMED Support**: Actor registration, UDI management, and certificate management
* **GDPR Article 27 Representation**: EU/UK representative services for data protection compliance
* **Testing Services**: Comprehensive medical device testing including EMC, biocompatibility, and sterilization validation
* **Software Solutions**: eIFU platforms, GUDID submission tools, and EUDAMED M2M integration
**Reputation / proof points**
* ISO 13485:2016 certified quality management system
* Recognized by major Notified Bodies across Europe
* Successfully supported 500+ medical device registrations
* Team of 50+ regulatory experts across 12 countries
* Member of RAPS, MedTech Europe, and other industry associations
* 98% client retention rate over the past 5 years
GlobalCompliance Solutions is a premier regulatory affairs consultancy with over 25 years of experience helping medical device manufacturers navigate complex global regulatory landscapes. Founded in 1999, we have established ourselves as trusted partners for companies ranging from startups to Fortune 500 enterprises.
**Expertise & scope**
Our comprehensive service portfolio covers all aspects of medical device regulatory compliance, including:
* **EU Authorized Representative Services**: Full MDR and IVDR compliance support for European market access
* **UK Responsible Person Services**: MHRA registration and ongoing regulatory support
* **FDA U.S. Agent Services**: Complete FDA registration, 510(k) submissions, and QSR compliance
* **PRRC Services**: Qualified Person Responsible for Regulatory Compliance as a service
* **EUDAMED Support**: Actor registration, UDI management, and certificate management
* **GDPR Article 27 Representation**: EU/UK representative services for data protection compliance
* **Testing Services**: Comprehensive medical device testing including EMC, biocompatibility, and sterilization validation
* **Software Solutions**: eIFU platforms, GUDID submission tools, and EUDAMED M2M integration
**Reputation / proof points**
* ISO 13485:2016 certified quality management system
* Recognized by major Notified Bodies across Europe
* Successfully supported 500+ medical device registrations
* Team of 50+ regulatory experts across 12 countries
* Member of RAPS, MedTech Europe, and other industry associations
* 98% client retention rate over the past 5 years
Additional information
**Response times**
We typically respond to RFQs within 24 hours and can begin onboarding within 7-14 business days.
**Pricing**
Our pricing is customized based on your specific needs, portfolio size, and service requirements. Starting from €5,000 annually for basic representation services.
**Languages supported**
English, French, German, Spanish, Italian, Dutch, Portuguese, and Japanese.
**Office locations**
* Boston, USA (Headquarters)
* London, UK
* Frankfurt, Germany
* Tokyo, Japan
We typically respond to RFQs within 24 hours and can begin onboarding within 7-14 business days.
**Pricing**
Our pricing is customized based on your specific needs, portfolio size, and service requirements. Starting from €5,000 annually for basic representation services.
**Languages supported**
English, French, German, Spanish, Italian, Dutch, Portuguese, and Japanese.
**Office locations**
* Boston, USA (Headquarters)
* London, UK
* Frankfurt, Germany
* Tokyo, Japan
Pricing
Model:
Custom pricing
Public range:
Starting from €5,000 annually
Notes:
Custom pricing based on portfolio size and requirements
HQ:
Boston, US
Website:
globalcompliance-solutions.com
Public email:
cruxi@cruxi.ai
Phone:
+1-617-555-0100
Languages:
English, French, German, Spanish
Timezones:
America/New_York, Europe/London, Europe/Berlin
Status:
pro
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Alternate Names:
EC REP, EU REP, EU Authorized Representative
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Post Market Support:
Yes
Labeling Review:
Yes
EU Entity Country:
Germany
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
uk_rp
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Supports GB:
Yes
Supports NI:
Yes
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
MHRA Support:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
Yes
Vigilance Support:
Yes
ch_rep
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
Swiss Local Contact:
Yes
Labeling Support:
Yes
Swiss Entity Canton Or Region:
Zurich
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
us_agent_fda
Jurisdictions:
US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Annual Renewal Support:
Yes
Registration Support:
Yes
Time Zone Coverage:
EST, PST
Inspection Support:
Yes
Emergency Contact24x7:
Yes
Annual Renewal Reminder:
Yes
Product Type:
devices
gdpr_art27_rep
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Coverage:
EU, UK, EU+UK
Languages:
English, French, German, Spanish
Dsar Slahours:
72
Regulator Contact Slahours:
24
Pricing Basis:
by_scale
Supports Special Category Data:
Yes
Supports Children Data:
Yes
Supports Biometric Data:
Yes
Supports Health Data:
Yes
Dpa Available:
Yes
Subprocessor List Available:
Yes
Breach Notification SLA:
24h
Dsar Workflow Support:
Full managed
Regulator Comms Handling:
Respond with client approval
dsa_art13_rep
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Notice And Action Handling:
Yes
Languages:
English, French, German, Spanish
Escalation Process:
Yes
EU Entity Country:
Ireland
Notice Handling SLA:
24h
Out Of Hours Contact:
Yes
Regulator Comms Handling:
Respond with client approval
cosmetics_rp
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Supports CPNP:
Yes
Supports PIF:
Yes
Product Categories:
Skincare, Haircare, Makeup, Fragrance
Label Review Included:
Yes
Supports CPSR:
Yes
Supports Claims Substantiation:
Yes
Supports Ukcosmetics Rp:
Yes
Can Provide Local Address On Label:
Yes
Turnaround SLA:
3-7 days
weee_epr_rep
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Streams Supported:
Packaging, WEEE, Batteries
Reporting Support:
Yes
Multi Country Management:
Yes
Reporting Frequency:
Quarterly
Marketplace Support:
Yes
Portals Handled:
LUCID, EAR
Eco Modulation Support:
Yes
reach_only_rep
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Supports Ukreach:
Yes
Dossier Support:
Yes
Substances Supported Count Max:
1000
Consortium Support:
Yes
Iuclid Dossier Support:
Yes
Supports Clp:
Yes
Substance Portfolio Complexity:
Medium
vat_fiscal_rep
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Supports Vatregistration:
Yes
Supports Filings:
Yes
Supports Oss Ioss:
Yes
Supports Einvoicing:
Yes
Supports Intrastat:
Yes
Importer Of Record Support:
Yes
VAT Refund Support:
Yes
prrc_service
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Named PRRC:
Yes
Availability Hours:
Extended hours
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
PRRC Qualification Summary:
Experienced PRRC with 15+ years in medical device regulatory affairs, certified in ISO 13485 and MDR compliance.
eudamed_reg_support
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, UDI/Devices, Certificates, Clinical investigations, Vigilance
Supports Training Enablement:
Yes
Data Load Support Level:
Done-for-you
Turnaround SLA:
3-7 days
importer_distributor_compliance
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Training Available:
Yes
Template Pack Available:
Yes
Deliverables:
SOPs, Templates pack, Training, Audit support, Ongoing retainer
Training Format:
Both
Role Coverage:
Both
eudamed_m2m
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Supported Modules:
Actor, UDI/Devices, Vigilance, Clinical Investigations, Certificates
Provides Access Point:
Yes
Domibus Based:
Yes
Provides Sandbox:
Yes
API Documentation Available:
Yes
Monitoring And Logs:
Yes
SLA For Errors:
24h
eifu_platform
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Hosting Model:
SaaS
Paper On Request Fulfillment:
Included
Multilingual Support:
Yes
Qr Or UDI Linking:
Yes
Validation Pack:
Yes
Implant Card Support:
Full
Compliance Certifications:
ISO 13485, MDR compliant
gudid_submission_tools
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Submission Route:
direct_spl
Generates Spl:
Yes
Handles Esgsubmission:
Yes
Validation Tools:
Yes
Gdsn Integration:
Yes
fda_qmsr_transition_inspection_readiness
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Service Types:
QMSR/ISO 13485 Gap Assessment, SOP / Documentation Remediation, Design Controls / DHF Modernization, Mock FDA Inspection, Training & Competency Programs
Earliest Start:
1_2_weeks
Delivery Mode:
Hybrid
Inspection Experience:
Former FDA investigator on team, Supports mock inspections regularly, ISO 13485 lead auditor capability
eu_ai_act_gpai_authorized_rep
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Response SLA:
48h
Coverage Window:
24/7 escalation
Service Scope:
Rep + readiness support
Contract Model:
Retainer
EU Member States:
DE, FR, ES, IT, NL, BE, SE, PL
Languages Supported:
English, French, German, Spanish
eu_ai_act_high_risk_compliance
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Delivery Type:
Full readiness package
Delivery Timeline:
8-12 weeks
Sector Experience:
Medtech
Scope:
Governance, Documentation, Risk management, Conformity support
eudamed_onboarding_support
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Modules Supported:
Actor/SRN, UDI/Devices, Certificates, Market Surveillance
Submission Approach:
Portal, Bulk Submissions, M2M Integration
Portfolio Fit:
100+
Onboarding Speed:
2-6 weeks
Managed Service Available:
Yes
Integration Support:
ERP/PLM mapping, Labeling mapping, Access point onboarding
medical_device_emc_testing
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Standards Supported:
IEC 60601-1, IEC 60601-1-2, IEC 61010-1
Test Coverage:
Both
Test Types Offered:
Conducted emissions, Radiated emissions, ESD immunity, RF immunity
Is Accredited:
Yes
Accreditation Body:
A2LA
Pre Scan Debug Support:
Yes
On Site Testing Option:
Yes
Lead Time Band:
Start in 2-4 weeks
Quote SLA:
24-48 hours
Rush Available:
Yes
Regions Served:
US, EU, UK
Sample Return Policy:
Return
Nda Support:
Yes
wireless_rf_testing
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Programs Supported:
FCC, CE RED, ISED Canada, UKCA
Is Accredited:
Yes
Accreditation Body:
A2LA
Tcb Relationship:
Yes
Red Notified Body Support:
Yes
Ised Support:
Yes
Sar Testing Capability:
Yes
Ota Testing Capability:
Yes
Supported Radios:
Wi-Fi, Bluetooth, LTE/5G, GNSS
Supported Bands:
2.4GHz, 5GHz, sub-GHz
Module Certification Support:
Yes
End Product Certification Support:
Yes
Lead Time Band:
Start in 2-4 weeks
Quote SLA:
24-48 hours
Rush Available:
Yes
Filing Support:
Yes
Regions Served:
US, EU, UK, CA
Sample Return Policy:
Return
Nda Support:
Yes
biocompatibility_testing
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity
Is Accredited:
Yes
Accreditation Body:
A2LA
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Rush Available:
No
Sample Requirements:
Minimum 3 samples per test type required
Sample Return Policy:
Dispose
Nda Support:
Yes
sterilization_microbiology_testing
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Sterilization Methods Supported:
EtO (Ethylene Oxide), Steam (Moist Heat), Gamma Radiation, E-Beam
Validation Types Offered:
Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Full validation (IQ/OQ/PQ)
Microbiology Tests Offered:
Bioburden, Sterility, Bacterial Endotoxin (LAL), Environmental monitoring
Standards Supported:
ISO 11135 (EtO), ISO 11137 (Radiation), ISO 17665 (Steam), ISO 11737-1 (Bioburden)
Is Accredited:
Yes
Accreditation Body:
A2LA
GMP Compliant:
Yes
Glp Compliant:
Yes
Has In House Sterilization:
Yes
Has In House Microbiology:
Yes
Lead Time Band:
Start in 2-4 weeks
Quote SLA:
24-48 hours
Rush Available:
Yes
Sample Requirements:
Minimum 10 samples per sterilization cycle
Sample Return Policy:
Dispose
Nda Support:
Yes
Regions Served:
US, EU, UK
packaging_shelf_life_testing
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Packaging Tests Offered:
Package integrity, Seal strength, Burst strength, Compression, Vibration, Drop
Standards Supported:
ISO 11607, ASTM D4169, ISTA, ISO 16775
Shelf Life Methods Offered:
Real-time aging, Accelerated aging, Both
Distribution Tests Offered:
Vibration, Shock, Drop, Compression, Stacking, Climate
Is Accredited:
Yes
Accreditation Body:
A2LA
Has Climate Chambers:
Yes
Has Distribution Simulation:
Yes
Max Shelf Life Years:
10
Lead Time Band:
Start in 2-4 weeks
Quote SLA:
24-48 hours
Rush Available:
Yes
Sample Requirements:
Minimum 5 samples per test type
Sample Return Policy:
Return
Nda Support:
Yes
Regions Served:
US, EU, UK
usability_human_factors_testing
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Usability Study Types Offered:
Formative study, Summative study, Both
Services Offered:
Study Design, Participant Recruitment, Data Analysis
Standards Supported:
IEC 62366-1, FDA Human Factors Guidance, ISO 14971
Has Participant Recruitment:
Yes
Has Usability Lab:
Yes
Has Remote Testing:
Yes
Is Accredited:
Yes
Accreditation Body:
A2LA
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Rush Available:
No
Sample Requirements:
Working prototype or device required
Nda Support:
Yes
Minimum Project Size:
$25-50k
Regions Served:
US, EU, UK
tga_sponsor_au
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Supports Artg:
Yes
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
Evidence Review:
Yes
Australian Entity State:
New South Wales
Recall Vigilance Support:
Yes
Fsca Recall Support:
Yes
jp_mah_dmah
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Offers MAH:
Yes
Offers DMAH:
Yes
PMDA Support:
Yes
Languages:
English, Japanese
Local License Capability:
Yes
Translation Support:
Yes
GMP Qmssupport:
Yes
Regulatory Liaison PMDA:
Yes
br_local_rep
Jurisdictions:
EU, UK, US
Countries:
DE, FR, GB, US
Portfolio:
1-5, 6-25, 26-100, 100+
Response SLA:
24 hours
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Supports Cadastro:
Yes
Supports Registro:
Yes
Portuguese Support:
Yes
Local License Capability:
Yes
Translation Support Ptbr:
Yes
Post Market Support:
Yes
Product Categories Supported:
IVD, SaMD, Implants, Consumables
