mdi Consultants
mdi Consultants, Inc.
Assistance to initial importer and distributors
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**<br>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.<br><br>**Expertise & scope**<br>* U.S. Agent representation for foreign medical device, pharmaceutical, food, and cosmetic manufacturers.<br>* Ensuring seamless communication and compliance with FDA regulations.<br>* Facilitating FDA facility registration, product listing, and marketing authorization applications for foreign entities.<br>* Providing FDA compliance consulting for medical device, pharmaceutical, and food industries.<br>* Offering services for Abbreviated New Drug Application (ANDA) submissions and Drug Master File (DMF) submissions.<br>* Assisting with FDA Quality System Strategy and clinical trial management for pharmaceuticals.<br>* Expertise in risk management for businesses in federally regulated environments, including adverse event disclosure and liability exposure.<br><br>**Reputation / proof points**<br>* 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
- mdi Consultants has been providing FDA compliance services since 1978.
- Specializes in U.S. Agent representation for foreign manufacturers in the medical device, pharmaceutical, and food industries.
- Facilitates FDA facility registration, product listing, and marketing authorization applications.
Certifications & Trust Signals
- Acts as Official Correspondent for domestic companies and U.S. Agent/Official Correspondent for foreign companies.
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
Website:
mdiconsultants.com
Public email:
info@mdiconsultants.com
Phone:
516-482-9001
Languages:
English, Spanish
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Status:
pro
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
Product Type:
devices
Annual Renewal Support:
Yes
Registration Support:
Yes
Recall Support:
Yes
Time Zone Coverage:
US Eastern, US Central, US Mountain, US Pacific, GMT, CET, CEST, JST, AEST, BRT
Inspection Support:
Yes
Emergency Contact24x7:
No
Annual Renewal Reminder:
Yes
510k_submission_services
Jurisdictions:
US
Countries:
US
Industries:
Medical devices, IVD, Foods, Cosmetics
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
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), 510(k) eSTAR Preparation, 510(k) RTA Remediation / Refuse-to-Accept Fix, Labeling Review for Submission (510(k)/De Novo/PMA)
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 Estar:
Yes
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Supports Labeling Review:
Yes
Provides Submission Project Management:
Yes
Years Experience:
48
Num510k Submitted:
4500
Ex FDA:
Yes
Ex Notified Body:
No
Ex Big Medtech:
No
Engagement Models:
fixed_fee
Accepting New Clients:
Yes
fda_qmsr_transition_inspection_readiness
Jurisdictions:
US
Countries:
United States
Industries:
Medical Devices, IVD
Portfolio:
100+
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Service Types:
QMSR/ISO 13485 Gap Assessment, Design Controls / DHF Modernization, Internal Audit Program Upgrade, Supplier Controls / Quality Agreements, CAPA & Nonconformance Remediation, Mock FDA Inspection, Training & Competency Programs, 483 Response & Remediation Support, SOP / Documentation Remediation
Inspection Experience:
Former FDA investigator on team, Supports mock inspections regularly, ISO 13485 lead auditor capability, MDSAP experience
importer_distributor_compliance
Jurisdictions:
US
Countries:
United States
Industries:
Medical Devices, IVD, SaMD, Pharmaceuticals, Cosmetics
Portfolio:
100+
Response SLA:
24 hours
Onboarding time:
2–7 days
Pricing model:
Custom pricing
Training Available:
Yes
Template Pack Available:
Yes
Deliverables:
SOPs, Audit support, Ongoing retainer, Templates pack, Training
Role Coverage:
Both
gudid_submission_tools
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
