Regulatory Excellence Group

Council on Licensure, Enforcement and Regulation

CLEAR is the premier international resource for professional and occupational regulation stakeholders, fostering collaboration and best practices for enhanced public protection.

The Council on Licensure, Enforcement and Regulation (CLEAR) is the largest international network dedicated to professional and occupational regulators. CLEAR serves as a premier resource, bringing together stakeholders for the exchange of information, education, and training. The organization acts as a central information clearinghouse, identifying and sharing best practices to improve the quality and understanding of regulation, ultimately enhancing public protection. CLEAR is an association of individuals, agencies, and organizations committed to advancing regulatory excellence globally. Their headquarters are located in Nicholasville, KY, United States.

About

**Who they are**
Regulatory Excellence Group is an international resource for professional and occupational regulation stakeholders. They foster collaboration and best practices to enhance public protection.

**Expertise & scope**
* Premier international resource for regulation stakeholders
* Focus on collaboration and best practices
* Aims to enhance public protection

**Reputation / proof points**
* Coverage: EU, US
* Languages: English

Additional information

Regulatory Excellence Group serves as a key resource for entities involved in professional and occupational regulation. Their approach emphasizes fostering collaboration among stakeholders to implement and share best practices. This focus aims to elevate public protection standards across the board. The organization's scope includes operations and engagement within both the European Union and the United States, with communication facilitated primarily in English.

Key Highlights

  • FDA QMSR transition specialists with extensive inspection readiness experience and quality system expertise. Source
    “FDA QMSR transition specialists with extensive inspection readiness experience and quality system expertise.”

Certifications & Trust Signals

  • Serving clients in US Source
    “Regulatory compliance expertise”

Buyer Snapshot

Best for
  • Organizations seeking to improve regulatory compliance and public protection.
  • Entities operating in or expanding to the EU and US markets.
  • Stakeholders in professional and occupational regulation.
How engagement typically works
  • Collaborative approach to best practices.
  • Focus on enhancing public protection.
Typical deliverables
  • Guidance on regulatory best practices.
  • Support for international regulatory alignment.
Good to know
  • Best when engagement requires a focus on collaboration and public protection within professional and occupational regulation.
HQ: Nicholasville, United States
Languages: English
Timezones: CST, EST
Status: listed

Services & Capabilities

FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment)

Jurisdictions: EU, US
Countries: US
Industries: Medical Devices
Onboarding time: 7–14 days
Pricing model: Custom pricing
Service Types: Training & Competency Programs

Additional fda_qmsr_transition_inspection_readiness Details

Service Types
QMSR/ISO 13485 Gap Assessment, SOP/Documentation Remediation, Design Controls/DHF Modernization, CAPA & Nonconformance Remediation, Supplier Controls/Quality Agreements, Internal Audit Program Upgrade, Mock FDA Inspection, Training & Competency Programs, 483 Response & Remediation Support
Earliest Start
flexible
Delivery Mode
Hybrid
Inspection Experience
Supports mock inspections regularly
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Cruxi - Regulatory Compliance Services