Compliance Insight, Inc.
Regulatory consulting firm specializing in FDA compliance for life sciences: services include U.S. Agent, registration & listing, audits, GMP/GCP, warning letter mitigation, quality systems, and regulatory submission support.
Compliance Insight, Inc. is a life sciences regulatory consulting firm helping companies in pharmaceuticals, biologics, and medical devices with FDA regulatory compliance. They offer FDA U.S. Agent and Official Correspondent services to assist foreign establishments with the FDA Unified Registration and Listing System (FURLS). They serve as the primary point of contact for the FDA regarding establishment registration and product listing. Additional services include regulatory submissions, audits, gap assessments, training, warning letter responses, GMP, GCP, and quality systems support.
About
**Who they are**
Compliance Insight, Inc. is a regulatory consulting firm focused on FDA compliance for life sciences companies.
**Expertise & scope**
* U.S. Agent services
* FDA establishment registration and listing
* Audits
* Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) support
* Warning letter mitigation
* Quality systems development and implementation
* Regulatory submission support
**Reputation / proof points**
* Serves the US market.
Compliance Insight, Inc. is a regulatory consulting firm focused on FDA compliance for life sciences companies.
**Expertise & scope**
* U.S. Agent services
* FDA establishment registration and listing
* Audits
* Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) support
* Warning letter mitigation
* Quality systems development and implementation
* Regulatory submission support
**Reputation / proof points**
* Serves the US market.
Additional information
Compliance Insight, Inc. provides specialized support for life sciences companies navigating FDA regulations. Their services are designed to ensure adherence to U.S. requirements, covering critical areas such as product registration, quality systems, and responding to regulatory actions. Companies engaging Compliance Insight, Inc. can expect assistance with maintaining compliance throughout the product lifecycle, from initial registration to ongoing quality management and addressing any potential compliance issues.
Key Highlights
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Specializes in FDA compliance for life sciences.
Source
“Regulatory consulting firm specializing in FDA compliance for life sciences”
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Offers comprehensive regulatory consulting services.
Source
“services include U.S. Agent, registration & listing, audits, GMP/GCP, warning letter mitigation, quality systems, and regulatory submission support.”
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Provides U.S. Agent services.
Source
“services include U.S. Agent”
Certifications & Trust Signals
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Adheres to Canadian Federal law (PIPEDA) for privacy.
Source
“Canadian Federal law (PIPEDA) requires that we provide you with our privacy policy”
Buyer Snapshot
Best for
- Life sciences companies requiring FDA compliance support
- Companies needing a U.S. Agent
How engagement typically works
- Consulting services for regulatory affairs
- Support for FDA registration and listing
Typical deliverables
- U.S. Agent representation
- FDA registration and listing services
- Audit support
- Quality system guidance
- Warning letter response strategies
Good to know
- Best when focused on FDA regulated products in the life sciences sector.
HQ:
Kitchener, Canada
Languages:
English
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Status:
listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, IVD
Portfolio:
6-25
Onboarding time:
2–7 days
Pricing model:
Retainer
Starting from:
USD 600
Included services:
FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders
Time Zone Coverage:
EST
Registration Support:
Yes
Product Type:
devices
Service Types:
US Agent Services, FDA Registration/Listing Support, Inspection Support, FDA Submissions (510(k), PMA, IDE, etc.), Product/Device Listing, Regulatory Consulting, Training/Education
Additional us_agent_fda Details
Included Services Detailed
Designation support and onboarding checklist for foreign establishment U.S. Agent setup, FDA communications receipt, acknowledgment, and routing to your designated contacts, Inspection scheduling support and operational readiness escalation (when applicable), Annual registration renewal reminders and administrative coordination
Excluded Services
Acting as importer of record, Commercial distribution management, Legal representation in enforcement actions
Onboarding Steps
Intake → designate contacts → confirm scope → activate communications workflow
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Life sciences products
Registration Support
Yes
Recall Support
Yes, through warning letter mitigation
Inspection Support
Yes, through audits
Emergency Contact24x7
No
