Boyd Consultants
John T. Boyd Company
Regulatory affairs firm offering U.S. Agent services for foreign drug and device manufacturers: handles FDA liaison, inspection coordination, registration/filing support, and submission document signing.
Boyd Consultants (Boyds) is a regulatory affairs and biotech consultancy specializing in drug development and regulatory affairs. They assist global biopharma firms with FDA submissions (INDs, NDAs, BLAs, etc.), offer US Agent / Authorized Representative services, gap assessments, and lifecycle regulatory strategy. They act as US agent, liaise with FDA, support registrations and device/drug sponsor communications, and help with inspection coordination.
About
**Who they are**
Boyd Consultants is a regulatory affairs firm that provides U.S. Agent services.
**Expertise & scope**
* Serves as a liaison with the FDA for foreign drug and device manufacturers.
* Coordinates FDA inspections.
* Offers support for registration and filing processes.
* Handles the signing of submission documents.
**Reputation / proof points**
* Operates in the US.
* Services are available in English.
Boyd Consultants is a regulatory affairs firm that provides U.S. Agent services.
**Expertise & scope**
* Serves as a liaison with the FDA for foreign drug and device manufacturers.
* Coordinates FDA inspections.
* Offers support for registration and filing processes.
* Handles the signing of submission documents.
**Reputation / proof points**
* Operates in the US.
* Services are available in English.
Additional information
Boyd Consultants focuses on regulatory affairs for foreign manufacturers seeking to engage with the U.S. Food and Drug Administration (FDA). Their services are designed to facilitate compliance by acting as a direct point of contact for FDA communications. This includes managing the administrative and procedural aspects of registration and filing, as well as being available for critical communication during inspections. Their role as a U.S. Agent is crucial for entities that do not have a physical presence in the United States, ensuring that regulatory requirements are met efficiently.
Key Highlights
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Provides U.S. Agent services for foreign drug and device manufacturers.
Source
“Regulatory affairs firm offering U.S. Agent services for foreign drug and device manufacturers: handles FDA liaison, inspection coordination, registration/filing support, and submission document signing.”
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Handles FDA liaison, inspection coordination, and submission document signing.
Source
“handles FDA liaison, inspection coordination, registration/filing support, and submission document signing.”
Certifications & Trust Signals
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Operates with offices in the United States (Canonsburg, Denver), Australia (Brisbane), and China (Beijing).
Source
“United States - Canonsburg (HQ) United States - Denver, Colorado”
Buyer Snapshot
Best for
- Foreign drug manufacturers
- Foreign device manufacturers
How engagement typically works
- FDA liaison
- Inspection coordination
Typical deliverables
- Registration and filing support
- Submission document signing
Good to know
- Best when a U.S. Agent is required for FDA compliance.
HQ:
US
Languages:
English
Timezones:
EST, PST
Claim status:
Listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical Devices, Pharmaceuticals, Biotech
Onboarding time:
3–14 days
Pricing model:
Custom pricing
Product Type:
devices, food, cosmetics, drugs
Service Types:
US Agent Services, FDA Registration/Listing Support, Inspection Support, FDA Submissions (510(k), PMA, IDE, etc.)
Registration Support:
Yes
Recall Support:
No
Inspection Support:
Yes
Emergency Contact24x7:
No
Additional us_agent_fda Details
Product Types
drugs, devices
Registration Support
Yes
Recall Support
No
Inspection Support
Yes
Emergency Contact24x7
No
US Entity State
US
Onboarding Steps
Insufficient unique content to generate onboardingSteps without boilerplate
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