ELS Group

ELS SOLUTIONS GDIA, UNIPESSOAL, LDA

ELS Group is a company with deep technical expertise and market access in Regulatory Affairs and Quality Assurance, duly certified. With 18 years of experience, we provide strategic solutions.

About

ELS Group is a company with deep technical expertise and market access in Regulatory Affairs and Quality Assurance, duly certified.<br><br>With 18 years of experience, we provide strategic, effective, comprehensive, yet simple solutions, including EU GMP certification, audit services, gap analysis and feasibility studies, technical consulting, and registration of both companies and products.<br><br>Our expertise spans medical devices, pharmaceuticals, dietary supplements, foods, cosmetics, sanitizing products, and medical cannabis in global markets.<br><br>We work diligently every day to deliver time and innovation to our clients by accelerating product launches, executing full-scale mergers and acquisitions (M&amp;A), rapidly closing new business opportunities, and ensuring efficient registration of new services.<br><br>We operate across three main verticals:<br>1. R&amp;D and Patents: Integrated CROs to accelerate innovation and secure intellectual property protection, allowing us to conduct preclinical tests, clinical trials, patent processes, and more.<br>2. Regulatory and Quality Assurance: A 100% pharmaceutical team specialized in 11 global markets, offering medical device registration, hosting services, ISO 13485 certification, GMP certification, and more.<br>3. Import and Distribution: A proprietary distribution network, distributor qualification, and strategic support for public sector entry. We conduct strategic distributor recruitment and manage a database of over 6,000 qualified distributors, among other services.

Additional information

Our mission is to be an indispensable reference for market access to innovation in the pharmaceutical industry and a driving force for growth in global markets.

Key Highlights

  • Specialized pharmaceutical team with expertise in 11 global markets.
  • Offers ISO 13485 and 9001 certifications, and GMP certification.
  • Manages a database of over 6,000 qualified distributors.

Certifications & Trust Signals

  • Founded with a focus on R&D and Patents, Regulatory and Quality Assurance, and Import and Distribution.

Buyer Snapshot

Best for
  • Companies seeking medical device registration and global market access.
  • Organizations needing support with pharmaceutical R&D and patent processes.
  • Businesses requiring import and distribution network management.
How engagement typically works
  • Project-based support for specific regulatory or R&D needs.
  • Strategic partnership for market entry and distribution.
  • Consultative approach to quality assurance and certification.
Typical deliverables
  • Medical device registration dossiers.
  • Clinical trial support documentation.
  • Patent process management.
  • ISO and GMP certification guidance.
  • Distributor qualification reports.
Good to know
  • Best when requiring specialized expertise in pharmaceutical and medical device regulations.
  • Suitable for companies looking to establish or expand international distribution.
HQ: Estoril, Portugal
Claim status: Claimed

Services & Capabilities

Best EU Authorized Rep (EC REP) | Compare & Get Quotes

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL, United States, United Kingdom, Canada, Germany, France, Italy, Spain, Netherlands, Belgium, Switzerland, Austria, Sweden, Denmark, Norway, Finland, Poland, Ireland, Portugal, Greece, Czech Republic, Romania, Brazil, Mexico, Argentina, Colombia, Chile
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements, Medical Devices, IVD, SaMD, Pharmaceuticals, Cosmetics, Electronics, Consumer Goods, Food & Beverage
Portfolio: 100+, 1-5, 6-25, 26-100
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Supports MDR: Yes
Supports IVDR: Yes
Device Classes Supported: Class I, Class IIb, Class III, Class Is/Im/Ir, Class IIa, IVD
Post Market Support: Yes
Labeling Review: Yes
Can Be Named On Label: Yes
Vigilance Contact Support: Yes
Fsca Recall Support: Yes

uk_rp

Jurisdictions: UK, EU, Global, BR, US, CH, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Portfolio: 100+, 1-5, 6-25, 26-100
Flags: high_portfolio, smd_samd, implantable, high_risk_processing, sterile, measuring, multi_language_support, class_iii, ivd, fast_onboarding, multi_country_coverage
Response SLA: 24 hours
Pricing model: Custom pricing
Supports GB: Yes
Supports NI: Yes
Device Classes Supported: Class I, Class III, IVD, Class IIa, Class IIb
MHRA Support: Yes
Can Be Named On Label: Yes
MHRA Portal Support: Yes
Vigilance Support: Yes

eudamed_onboarding_support

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL, United States, United Kingdom, Canada, France, Germany, Italy, Spain, Netherlands, Belgium, Switzerland, Austria, Sweden, Denmark, Norway, Finland, Poland, Ireland, Portugal, Greece, Czech Republic, Romania, Brazil, Argentina, Mexico, Colombia, Chile
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements, Medical Devices, IVD, Pharmaceuticals, SaMD, Cosmetics, Consumer Goods, Electronics, Food & Beverage
Portfolio: 100+, 1-5, 6-25, 26-100
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Modules Supported: Actor/SRN, Market Surveillance, UDI/Devices, Certificates
Submission Approach: M2M Integration, Portal, Bulk Submissions
Portfolio Fit: 100+
Onboarding Speed: 1-2 weeks
Managed Service Available: Yes
Integration Support: Access point onboarding, Labeling mapping, ERP/PLM mapping

cosmetics_rp

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL, United States, United Kingdom, Canada, France, Germany, Italy, Spain, Belgium, Netherlands, Austria, Switzerland, Sweden, Denmark, Norway, Finland, Poland, Ireland, Portugal, Greece, Czech Republic, Romania, Brazil, Mexico, Argentina, Colombia, Chile
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements, Medical Devices, IVD, SaMD, Pharmaceuticals, Cosmetics, Electronics, Consumer Goods, Food & Beverage
Portfolio: 100+, 1-5, 6-25, 26-100
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, ivd, class_iii
Response SLA: 24 hours
Pricing model: Custom pricing
Supports CPNP: Yes
Supports PIF: Yes
Product Categories: IVD, Class III, SaMD, Implants, Consumables, Active devices, Software, Class I, Class IIa, Class IIb
Label Review Included: No
Supports CPSR: Yes
Supports Regulatory Consulting: Yes
Supports Formula Compliance Checks: Yes
Supports Testing Coordination Management: Yes
Supports Claims Substantiation: Yes
Supports Ukcosmetics Rp: Yes
Can Provide Local Address On Label: Yes
Turnaround SLA: Custom

ch_rep

Jurisdictions: EU, UK, CH, US, BR, Global
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 100+
Flags: multi_country_coverage, high_portfolio, smd_samd, implantable, high_risk_processing, fast_onboarding, multi_language_support, sterile, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Device Classes Supported: Class I, Class III, IVD, Class IIa, Class IIb
Swiss Local Contact: Yes
Labeling Support: Yes
Can Be Named On Label: Yes
Vigilance Contact Support: Yes

swiss_fadp_rep

Jurisdictions: EU, UK, CH, BR, Global, US, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 6-25, 1-5, 26-100, 100+
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
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: Custom

prrc_service

Jurisdictions: EU, UK, OTHER, CH, US, BR, Global
Countries: EU-wide;UK;CH;US;BR;GLOBAL, United States, United Kingdom, Canada, Germany, France, Italy, Netherlands, Spain, Belgium, Switzerland, Austria, Sweden, Denmark, Norway, Finland, Poland, Ireland, Portugal, Greece, Czech Republic, Romania, Brazil, Mexico, Argentina, Chile, Colombia
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements, Medical Devices, SaMD, Cosmetics, Electronics, Pharmaceuticals, Consumer Goods, IVD, Food & Beverage
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Named PRRC: Yes
Device Classes Supported: Class I, Class IIb, Class III, Class Is/Im/Ir, Class IIa, IVD
PRRC Qualification Summary: Specialized pharmaceutical team with expertise in global markets and regulatory compliance.

eudamed_reg_support

Jurisdictions: EU, UK, CH, US, BR, Global
Countries: EU-wide;UK;CH;US;BR;GLOBAL, United States, United Kingdom, Canada, Germany, Italy, France, Spain, Netherlands, Belgium, Switzerland, Austria, Sweden, Denmark, Norway, Finland, Poland, Ireland, Portugal, Greece, Czech Republic, Romania, Brazil, Mexico, Argentina, Colombia, Chile
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements, Medical Devices, SaMD, IVD, Pharmaceuticals, Cosmetics, Electronics, Consumer Goods, Food & Beverage
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Supports Actor Registration: Yes
Supports UDI: Yes
Supports Data Load: Yes
Modules Supported: Actor/SRN, Vigilance, Clinical investigations, Certificates, UDI/Devices, Not sure
Supports Training Enablement: Yes

br_local_rep

Jurisdictions: EU, UK, OTHER, CH, US, BR, Global
Countries: EU-wide;UK;CH;US;BR;GLOBAL, United Kingdom, United States, Canada, Germany, Italy, France, Netherlands, Spain, Belgium, Switzerland, Austria, Denmark, Sweden, Norway, Finland, Poland, Ireland, Portugal, Greece, Czech Republic, Romania, Brazil, Mexico, Argentina, Colombia, Chile
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements, Medical Devices, IVD, Pharmaceuticals, SaMD, Cosmetics, Electronics, Consumer Goods, Food & Beverage
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
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, Active devices, Software, Class I, Class IIa, Class IIb, Class III

eudamed_m2m

Jurisdictions: EU, UK, CH, US, BR, Global
Countries: United States, United Kingdom, Canada, Germany, France, Italy, Spain, Netherlands, Belgium, Switzerland, Austria, Sweden, Denmark, Norway, Finland, Poland, Ireland, Portugal, Greece, Czech Republic, Romania, Brazil, Mexico, Argentina, Colombia, Chile, Global
Industries: Medical Devices, IVD, SaMD, Pharmaceuticals, Cosmetics, Electronics, Consumer Goods, Food & Beverage
Portfolio: 1-5, 6-25, 100+, 26-100
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Supported Modules: Actor, Clinical Investigations, Certificates, UDI/Devices, Vigilance
Provides Access Point: Yes
Domibus Based: Yes
Provides Sandbox: Yes
API Documentation Available: Yes
Monitoring And Logs: Yes

medical_device_cybersecurity

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: sterile, implantable, smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Service Categories: Threat Modeling & Risk Analysis, SBOM Management (Software Tool), Penetration Testing (Manual/Hardware), RTA Rescue (Submission Fix), Vulnerability Management (Post-Market)
Submission Stage Support: Pre-Submission (Planning), Ready for 510(k)/MDR Submission, RTA Fix (FDA Refusal Response)
Device Types Supported: Hospital/Enterprise Systems, Connected Hardware (IoT/WiFi/Bluetooth), Software as a Medical Device (SaMD), Other
Sbom Formats Supported: Other, CycloneDX, SPDX
Standards Frameworks: ISO 13485, ISO 9001, GMP
Pen Testing Available: Yes
Threat Modeling Available: Yes
Sbom Management Available: Yes
Vulnerability Monitoring Available: Yes
Rta Rescue Available: Yes

eu_ai_act_gpai_authorized_rep

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: implantable, smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, multi_language_support, sterile, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Coverage Window: Business hours
Service Scope: Rep + readiness support
Contract Model: Custom
Languages Supported: English, German, French, Spanish, Italian, Portuguese

eu_ai_act_high_risk_compliance

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Delivery Type: Full readiness package
Delivery Timeline: custom
Sector Experience: Medtech
Scope: Governance, Conformity support, All-in-one, Documentation, Risk management

510k_submission_services

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: implantable, smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, multi_language_support, sterile, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Services Offered: Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, Medical Device Reimbursement, 510(k) eSTAR Preparation, Traditional 510(k) Support, Abbreviated 510(k) Support, 510(k) RTA Remediation / Refuse-to-Accept Fix, PMA Strategy & Support, De Novo Strategy & Authoring, Predicate Research & Substantial Equivalence Strategy, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Labeling Review for Submission (510(k)/De Novo/PMA), Submission Project Management (end-to-end)
Pathways Supported: Traditional 510(k), De Novo, PMA, Special 510(k), Abbreviated 510(k), Pre-Sub / Q-Sub
Device Types Supported: Medical device, Combination product, Other, IVD, SaMD
Supports Estar: Yes
Supports Rta Remediation: Yes
Supports Predicate Research: Yes
Supports Labeling Review: Yes
Provides Submission Project Management: Yes
Ex FDA: Yes
Ex Notified Body: Yes
Ex Big Medtech: Yes
Accepting New Clients: Yes

gdpr_art27_rep

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: sterile, implantable, smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Supports Special Category Data: Yes
Supports Children Data: Yes
Supports Biometric Data: Yes
Supports Health Data: Yes
Dpa Available: Yes
Subprocessor List Available: Yes

us_agent_fda

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: high_portfolio, multi_country_coverage, smd_samd, implantable, high_risk_processing, fast_onboarding, multi_language_support, sterile, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Product Type: devices, drugs, food, cosmetics
Annual Renewal Support: Yes
Registration Support: Yes
Recall Support: Yes
Time Zone Coverage: US Eastern, US Central, US Mountain, US Pacific, BRT, GMT, CET
Inspection Support: Yes
Emergency Contact24x7: Yes
Annual Renewal Reminder: Yes

gpsr_rep

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, measuring, sterile, multi_language_support, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Product Categories Supported: consumer_electronics, apparel_textiles, personal_care, other, furniture, toys_children, beauty_cosmetics, outdoor_garden, home_kitchen, sporting_goods
Sales Channels Supported: wholesale, online_marketplace, own_website, fulfillment, other, retail
Provides Euaddress On Label: Yes
Supports Risk Assessment: Yes
Supports Technical Documentation: Yes
Supports Incident Reporting: Yes
Supports Recall Management: Yes
Traceability Support: Yes

importer_distributor_compliance

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: multi_country_coverage, high_portfolio, smd_samd, implantable, high_risk_processing, fast_onboarding, sterile, multi_language_support, measuring, ivd, class_iii
Response SLA: 24 hours
Pricing model: Custom pricing
Training Available: Yes
Template Pack Available: Yes
Deliverables: Audit support, SOPs, Templates pack, Ongoing retainer, Training

sterilization_microbiology_testing

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Sterilization Methods Supported: EtO (Ethylene Oxide), E-Beam, Vaporized Hydrogen Peroxide, Other, X-Ray, Steam (Moist Heat), Gamma Radiation, Plasma
Validation Types Offered: Installation Qualification (IQ), Full validation (IQ/OQ/PQ), Revalidation, Operational Qualification (OQ), Performance Qualification (PQ), Other
Microbiology Tests Offered: Environmental monitoring, Other, Sterility, Bioburden, Bacterial Endotoxin (LAL)
Standards Supported: ISO 11135 (EtO), ISO 14937 (General), ISO 11138 (Biological indicators), Other, USP <1211>, ISO 11737-1 (Bioburden), ISO 11137 (Radiation), ISO 17665 (Steam), ISO 11737-2 (Sterility), USP <1229>
Is Accredited: Yes
GMP Compliant: Yes
Glp Compliant: Yes
Has In House Sterilization: Yes
Has In House Microbiology: Yes
Rush Available: Yes
Nda Support: Yes
Regions Served: United States, United Kingdom, Canada, Germany, France, Italy, Spain, Netherlands, Belgium, Switzerland, Austria, Sweden, Denmark, Norway, Finland, Poland, Ireland, Portugal, Australia, Japan, China, India, Singapore, South Korea, Brazil, Mexico, Global, EU-wide

biocompatibility_testing

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: high_portfolio, smd_samd, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Iso10993 Standards Supported: ISO 10993-1, ISO 10993-11, ISO 10993-33, USP <87>, ISO 10993-12, ISO 10993-5, ISO 10993-10, ISO 10993-18, USP <88>, Other
Test Types Offered: Cytotoxicity, Sensitization, Irritation, Implantation, Genotoxicity, Systemic toxicity, Hemocompatibility, Pyrogenicity, Carcinogenicity, Pharmacokinetics, Biodegradation, Reproductive toxicity, Other
Is Accredited: Yes
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)
Rush Available: Yes
Nda Support: Yes
Regions Served: United States, United Kingdom, Canada, Germany, France, Italy, Spain, Netherlands, Belgium, Switzerland, Austria, Sweden, Denmark, Norway, Finland, Poland, Ireland, Portugal, China, India, Singapore, South Korea, Brazil, Mexico, Global, EU-wide, APAC, Americas

usability_human_factors_testing

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: multi_country_coverage, high_portfolio, smd_samd, implantable, high_risk_processing, fast_onboarding, multi_language_support, sterile, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Usability Study Types Offered: Summative study, Formative study, Both
Services Offered: Risk analysis, Instructions evaluation, Validation testing, Task analysis, Other, User interface evaluation
User Types Supported: Lay user, Professional healthcare, Both
Use Environments Supported: Home healthcare, Professional healthcare, Both
Standards Supported: FDA Human Factors Guidance, IEC 62366-2, IEC 62366-1, ISO 14971, Other
Has Participant Recruitment: Yes
Has Usability Lab: Yes
Has Remote Testing: Yes
Is Accredited: Yes
Lead Time Band: Start in 0-2 weeks
Quote SLA: 24-48 hours
Rush Available: Yes
Nda Support: Yes
Minimum Project Size: No minimum
Regions Served: United States, United Kingdom, Canada, Germany, France, Italy, Spain, Netherlands, Belgium, Switzerland, Austria, Sweden, Denmark, Norway, Finland, Poland, Ireland, Portugal, Brazil, Mexico, Global, EU-wide, South Korea, India, China

eqms_software_comparison

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: sterile, implantable, smd_samd, high_portfolio, high_risk_processing, multi_country_coverage, fast_onboarding, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Deployment Model: Hybrid
Modules Included: Document Control, Training Management, Risk Management, Other, Audit Management, Complaint Handling, CAPA, Change Control, Supplier Management, Design Control
Compliance Standards: FDA QMSR (21 CFR Part 820), ISO 13485:2016, 21 CFR Part 11, EU MDR/IVDR, ISO 14971, MDSAP, Other
Validation Pack Available: Yes
Part11 Support: Yes
Implementation Timeline: Custom
Data Migration Support: Yes
Training Support: Yes
API Access: Yes
Regions Served: United States, United Kingdom, Canada, Germany, France, Italy, Spain, Netherlands, Belgium, Switzerland, Austria, Sweden, Denmark, Norway, Finland, Poland, Ireland, Portugal, Australia, Japan

cbam_verification

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Sectors Covered: Cement, Iron and Steel, Multiple / Mixed, Other, Hydrogen, Aluminium, Fertilisers, Electricity
Accreditation Status: Yes
Languages Supported: English, Portuguese, Spanish, German, French, Italian
Regions Served: United States, United Kingdom, Canada, Germany, France, Italy, Spain, Netherlands, Belgium, Switzerland, Austria, Sweden, Denmark, Norway, Finland, Poland, Ireland, Portugal, Brazil, Mexico, Global, EU-wide
Experience With Cbam: Yes

medical_device_emc_testing

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 1-5, 6-25, 26-100, 100+
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Standards Supported: IEC 60601-1, IEC 60601-1-11, ISO/IEC 17025, IEC 60601-2-x, IEC 61010-1, IEC 60601-1-2, IEC 60601-1-2 Ed. 4
Test Coverage: Both
Is Accredited: Yes
Nrtl Relationships: UL, CSA, Other, TUV, Intertek
Cb Scheme Support: Yes
Pre Scan Debug Support: Yes
On Site Testing Option: Yes
Wireless Add On Capability: Yes
Rush Available: Yes
Test Types Offered: Conducted emissions, EFT immunity, Dips/interruptions, Voltage variations, Surge immunity, Radiated emissions, ESD immunity, RF immunity
Regions Served: United States, United Kingdom, Canada, Germany, France, Italy, Spain, Netherlands, Belgium, Switzerland, Austria, Sweden, Denmark, Norway, Finland, Poland, Ireland, Portugal, China, India, Singapore, South Korea, Brazil, Mexico, Global, EU-wide, Americas
Nda Support: Yes
Minimum Project Size: No minimum

wireless_rf_testing

Jurisdictions: EU, CH, UK, US, Global, BR, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 100+, 26-100, 6-25, 1-5
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Programs Supported: FCC, UKCA, Other, CE RED, ISED Canada
Is Accredited: Yes
Tcb Relationship: Yes
Red Notified Body Support: Yes
Ised Support: Yes
Sar Testing Capability: Yes
Ota Testing Capability: Yes
Supported Radios: Wi-Fi, GNSS, NFC, Bluetooth, Proprietary, LTE/5G, Other
Module Certification Support: Yes
End Product Certification Support: Yes
Lead Time Band: Start in 4-8 weeks
Quote SLA: 3-5 business days
Rush Available: Yes
Filing Support: Yes
Regions Served: United States, United Kingdom, Canada, Germany, France, Italy, Spain, Netherlands, Belgium, Switzerland, Austria, Sweden, Denmark, Norway, Finland, Poland, Ireland, Portugal, Singapore, Brazil, Mexico, Global, EU-wide, Americas, India, China
Nda Support: Yes
Minimum Project Size: No minimum

fda_qmsr_transition_inspection_readiness

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 100+, 1-5, 6-25, 26-100
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Service Types: QMSR/ISO 13485 Gap Assessment, CAPA & Nonconformance Remediation, Mock FDA Inspection, Training & Competency Programs, Supplier Controls / Quality Agreements, SOP / Documentation Remediation, Design Controls / DHF Modernization, Internal Audit Program Upgrade, 483 Response & Remediation Support
Earliest Start: flexible
Delivery Mode: Hybrid
Inspection Experience: Former FDA investigator on team, MDSAP experience, Supports mock inspections regularly, ISO 13485 lead auditor capability

gudid_submission_tools

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 100+, 1-5, 6-25, 26-100
Flags: smd_samd, high_portfolio, multi_country_coverage, fast_onboarding, high_risk_processing, implantable, sterile, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Generates Spl: Yes
Handles Esgsubmission: Yes
Validation Tools: Yes
Gdsn Integration: Yes

weee_epr_rep

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 100+, 1-5, 6-25, 26-100
Flags: high_portfolio, multi_country_coverage, smd_samd, implantable, high_risk_processing, sterile, fast_onboarding, multi_language_support, measuring, class_iii, ivd
Response SLA: 24 hours
Pricing model: Custom pricing
Streams Supported: Packaging, Textiles, Furniture, WEEE, Batteries, Other
Reporting Support: Yes
Multi Country Management: Yes
Reporting Frequency: Custom
Marketplace Support: Yes
Portals Handled: LUCID, EAR, CITEO, Eco-Emballages, Valpak, ERP
Eco Modulation Support: Yes

vat_fiscal_rep

Jurisdictions: EU, UK, CH, US, BR, Global, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 100+, 1-5, 6-25, 26-100
Flags: multi_country_coverage, high_portfolio, smd_samd, implantable, high_risk_processing, fast_onboarding, multi_language_support, sterile, measuring, class_iii, ivd
Response SLA: 24 hours
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

dsa_art13_rep

Jurisdictions: EU, UK, CH, US, Global, BR, OTHER
Countries: EU-wide;UK;CH;US;BR;GLOBAL
Industries: MedicalDevices;Pharmaceuticals;Cosmetics;Cannabis;Foods;Sanitizers;Supplements
Portfolio: 100+, 1-5, 6-25, 26-100
Flags: smd_samd, high_portfolio, multi_country_coverage, high_risk_processing, implantable, measuring, multi_language_support, sterile, class_iii, ivd, fast_onboarding
Response SLA: 24 hours
Pricing model: Custom pricing
Notice And Action Handling: Yes
Escalation Process: No
Notice Handling SLA: Custom
Out Of Hours Contact: No
Regulator Comms Handling: Full handling

Additional eu_ar Details

Supports MDR
true
Supports IVDR
true
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