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 the FDA liaison for foreign drug and device manufacturers. * Facilitates FDA inspection coordination. * Offers support for registration and filing processes. * Handles submission document signing.
**Reputation / proof points** * Operates with a focus on the US market. * Services are available in English.
Additional information
Boyd Consultants acts as a crucial point of contact for foreign entities needing to comply with U.S. Food and Drug Administration (FDA) regulations. Their services are designed to streamline the complex process of interacting with the FDA, ensuring that manufacturers of drugs and medical devices can navigate U.S. market requirements effectively. This includes managing official communications, coordinating site inspections, and assisting with the necessary documentation for submissions and registrations.
Key Highlights
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.”
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
Founded as John T. Boyd Company, indicating a long-standing presence in the industry.
Source
“John T. Boyd Company”
Buyer Snapshot
Best for
Foreign drug and device manufacturers requiring a U.S. Agent
How engagement typically works
Direct FDA liaison
Documentation support
Typical deliverables
FDA registration and filing support
Submission document signing
Inspection coordination
Good to know
Best when engaging with U.S. FDA for drug and device compliance
HQ: US
Languages: English
Timezones: EST, PST
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
Service Types: US Agent Services, FDA Registration/Listing Support, Inspection Support, FDA Submissions (510(k), PMA, IDE, etc.)
Additional us_agent_fda Details
Product Types
Drugs, Medical Devices
Registration Support
Yes
Recall Support
No
Inspection Support
Yes
Emergency Contact24x7
No
US Entity State
Insufficient unique content to generate usEntityState without boilerplate
Onboarding Steps
Insufficient unique content to generate onboardingSteps without boilerplate