mdi Consultants
mdi Consultants, Inc.
mdi Consultants offers expert FDA regulatory compliance services, specializing in U.S. Agent representation for foreign medical device, pharmaceutical, and food manufacturers. They ensure seamless communication and compliance with FDA regulations.
mdi Consultants, Inc. is a leading provider of FDA regulatory compliance consulting with over 45 years of experience. They specialize in assisting medical device, pharmaceutical, and food industry companies worldwide in achieving regulatory and standards compliance. Their services are crucial for foreign-based manufacturers who need a U.S. Agent to register their facilities, list products, and submit FDA marketing authorization applications without establishing a physical presence in the United States. As an experienced U.S. Agent to the FDA, mdi Consultants acts as an effective liaison between your company and the FDA. They manage all communications, including scheduling FDA inspections, handling import detention issues, and addressing compliance questions. Their expertise also extends to FDA legal counsel and risk management, particularly for businesses operating in federally regulated environments. mdi Consultants stays up-to-date with the latest FDA regulations and user fees, providing timely information and tailored consulting services. They are dedicated to helping international clients navigate the complexities of the U.S. market and maintain compliance with FDA requirements.
About
**Who they are**
mdi Consultants is a firm specializing in FDA regulatory compliance services, with a particular focus on acting as a U.S. Agent for foreign manufacturers. They have been guiding businesses through FDA processes since 1978.
**Expertise & scope**
* U.S. Agent representation for foreign medical device, pharmaceutical, food, and cosmetic manufacturers.
* Ensuring seamless communication and compliance with FDA regulations.
* Facilitating FDA facility registration, product listing, and marketing authorization applications for foreign entities.
* Providing FDA compliance consulting for medical device, pharmaceutical, and food industries.
* Offering services for Abbreviated New Drug Application (ANDA) submissions and Drug Master File (DMF) submissions.
* Assisting with FDA Quality System Strategy and clinical trial management for pharmaceuticals.
* Expertise in risk management for businesses in federally regulated environments, including adverse event disclosure and liability exposure.
**Reputation / proof points**
* Serving clients since 1978.
mdi Consultants is a firm specializing in FDA regulatory compliance services, with a particular focus on acting as a U.S. Agent for foreign manufacturers. They have been guiding businesses through FDA processes since 1978.
**Expertise & scope**
* U.S. Agent representation for foreign medical device, pharmaceutical, food, and cosmetic manufacturers.
* Ensuring seamless communication and compliance with FDA regulations.
* Facilitating FDA facility registration, product listing, and marketing authorization applications for foreign entities.
* Providing FDA compliance consulting for medical device, pharmaceutical, and food industries.
* Offering services for Abbreviated New Drug Application (ANDA) submissions and Drug Master File (DMF) submissions.
* Assisting with FDA Quality System Strategy and clinical trial management for pharmaceuticals.
* Expertise in risk management for businesses in federally regulated environments, including adverse event disclosure and liability exposure.
**Reputation / proof points**
* Serving clients since 1978.
Additional information
mdi Consultants emphasizes the critical role of a U.S. Agent for foreign companies seeking to enter the U.S. market. They highlight that a U.S. Agent must have a physical presence in the United States, not just a Post Office box or answering service, and must be available throughout business hours. Their services negate the necessity and expense of establishing a physical facility in the U.S. for foreign manufacturers. They also provide services related to FDA establishment registration renewal and drug listing certification, which are annual requirements for many companies.
Key Highlights
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mdi Consultants has been providing FDA compliance services since 1978.
Source
“Since 1978, our team of experienced consultants has been a trusted partner for hundreds of businesses, guiding them through the intricate FDA regulatory processes.”
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Specializes in U.S. Agent representation for foreign manufacturers in the medical device, pharmaceutical, and food industries.
Source
“mdi Consultants offers expert FDA regulatory compliance services, specializing in U.S. Agent representation for foreign medical device, pharmaceutical, and food manufacturers.”
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Facilitates FDA facility registration, product listing, and marketing authorization applications.
Source
“If you are a foreign based manufacturer*, and do not have a facility in the U.S., you will not be able to register your facility, list your products, or submit your FDA marketing authorization applications, unless you designate a U.S. Agent to the FDA.”
Certifications & Trust Signals
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Acts as Official Correspondent for domestic companies and U.S. Agent/Official Correspondent for foreign companies.
Source
“(Please note: mdi has been providing this service for many of our clients. For Domestic companies their Off. Corresp. and foreign companies their US Agent and Official Correspondent.)”
Buyer Snapshot
Best for
- Foreign manufacturers needing a U.S. Agent for FDA compliance.
- Companies seeking assistance with FDA registration and product listing.
- Businesses requiring regulatory guidance in the medical device, pharmaceutical, and food sectors.
How engagement typically works
- Direct communication and representation with the FDA.
- Proactive compliance management and strategic planning.
- Risk management and legal counsel for FDA-regulated industries.
Typical deliverables
- Designated U.S. Agent services.
- FDA establishment registration and product listing support.
- Regulatory compliance roadmaps and strategy.
- Submission services for ANDAs and DMFs.
Good to know
- Best when a physical U.S. presence is not feasible or desired by the foreign manufacturer.
HQ:
New York, US
Languages:
English
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Status:
claimed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, IVD, Foods, Cosmetics
Portfolio:
6-25
Response SLA:
24 hours
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
Annual Renewal Support:
Yes
Registration Support:
Yes
Inspection 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, Import Alert/Detention Resolution, Regulatory Consulting
510k_submission_services
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, IVD, Foods, Cosmetics
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, Special 510(k) Support, Traditional 510(k) Support, Abbreviated 510(k) Support, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, IVD
Supports Predicate Research:
Yes
Provides Submission Project Management:
Yes
Years Experience:
45
Num510k Submitted:
1800
Engagement Models:
fixed_fee
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
The website mentions providing updates of establishment registration and product listing, and being responsible for communications between the FDA and the Company.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Medical Devices, IVDs, Pharmaceuticals, Food, Cosmetics, Dietary Supplements, Biologicals
Registration Support
Yes
US Entity State
USA
Emergency Contact24x7
No
Recall Support
No
Inspection Support
No
