Regulatory Excellence Partners
Regulatory Excellence Partners LLC
★★★★★
4.8
/ 5
•
127 reviews
Boutique regulatory consultancy offering personalized, high-touch regulatory services for innovative medical device companies and startups.
About
**Who they are**
Regulatory Excellence Partners is a boutique regulatory affairs consultancy specializing in innovative medical devices, digital health solutions, and emerging technologies. Since our founding in 2010, we have built a reputation for providing personalized, strategic regulatory guidance to startups and established companies alike.
**Expertise & scope**
Our specialized services include:
* **FDA Strategy & Submissions**: 510(k), De Novo, PMA support, and breakthrough device designation guidance
* **EU MDR/IVDR Services**: Authorized representative services, technical documentation, and clinical evaluation reports
* **Digital Health & AI**: Regulatory strategy for SaMD, AI/ML-enabled devices, and software as a medical device
* **Quality Systems**: FDA QSR/ISO 13485 implementation, design controls, and risk management
* **Testing & Validation**: Coordination of EMC, biocompatibility, and usability testing programs
* **EUDAMED & UDI**: Complete EUDAMED onboarding, UDI assignment, and GUDID submission support
* **International Expansion**: Market entry strategies for EU, UK, Canada, Australia, and Asia-Pacific
* **Compliance Software**: eIFU platform integration and regulatory data management solutions
**Reputation / proof points**
* 15+ years of regulatory consulting experience
* Successfully guided 200+ innovative device launches
* Specialized expertise in Class II and Class III devices
* Strong track record with FDA breakthrough device program
* Team includes former FDA reviewers and Notified Body auditors
* 100% client satisfaction rating in 2023
Regulatory Excellence Partners is a boutique regulatory affairs consultancy specializing in innovative medical devices, digital health solutions, and emerging technologies. Since our founding in 2010, we have built a reputation for providing personalized, strategic regulatory guidance to startups and established companies alike.
**Expertise & scope**
Our specialized services include:
* **FDA Strategy & Submissions**: 510(k), De Novo, PMA support, and breakthrough device designation guidance
* **EU MDR/IVDR Services**: Authorized representative services, technical documentation, and clinical evaluation reports
* **Digital Health & AI**: Regulatory strategy for SaMD, AI/ML-enabled devices, and software as a medical device
* **Quality Systems**: FDA QSR/ISO 13485 implementation, design controls, and risk management
* **Testing & Validation**: Coordination of EMC, biocompatibility, and usability testing programs
* **EUDAMED & UDI**: Complete EUDAMED onboarding, UDI assignment, and GUDID submission support
* **International Expansion**: Market entry strategies for EU, UK, Canada, Australia, and Asia-Pacific
* **Compliance Software**: eIFU platform integration and regulatory data management solutions
**Reputation / proof points**
* 15+ years of regulatory consulting experience
* Successfully guided 200+ innovative device launches
* Specialized expertise in Class II and Class III devices
* Strong track record with FDA breakthrough device program
* Team includes former FDA reviewers and Notified Body auditors
* 100% client satisfaction rating in 2023
Additional information
**Response times**
Rapid response within 4-8 hours for urgent inquiries. Standard onboarding: 10-15 business days.
**Pricing**
Custom pricing based on project scope. Annual retainers starting from $6,000 USD. Per-project and hourly consulting options available.
**Languages supported**
English, Spanish, Mandarin, and Japanese.
**Office locations**
* San Francisco, USA (Headquarters)
* Austin, Texas
* Remote team across US and EU
Rapid response within 4-8 hours for urgent inquiries. Standard onboarding: 10-15 business days.
**Pricing**
Custom pricing based on project scope. Annual retainers starting from $6,000 USD. Per-project and hourly consulting options available.
**Languages supported**
English, Spanish, Mandarin, and Japanese.
**Office locations**
* San Francisco, USA (Headquarters)
* Austin, Texas
* Remote team across US and EU
Pricing
Model:
Custom pricing
Public range:
Starting from €5,000 annually
Notes:
Custom pricing based on portfolio size and requirements
HQ:
San Francisco, US
Website:
regulatoryexcellence.com
Public email:
cruxi@cruxi.ai
Phone:
+1-415-555-0200
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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+
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
