FDA Specialist
★★★★★
5.0
/ 5
•
17 reviews
FDASpecialist provides comprehensive FDA regulatory compliance services for foods, dietary supplements, cosmetics, medical devices, and drugs. Services include facility registration, US Agent services, product listings, label reviews, FSVP compliance, import hold/detention resolution, and import alert petitioning. Led by Richard Chiang, Owner and Chief Consultant.
FDA Specialist offers comprehensive services to navigate the complex landscape of FDA regulations. With extensive experience, including a former FDA specialist with 13 years of service, they provide expert guidance on food facility registration, medical device requirements, cosmetic regulations under MoCRA, and the FDA drug approval process. They are particularly adept at assisting foreign facilities by acting as a US agent, facilitating communication with the FDA, and helping to schedule inspections. Their services extend to ensuring compliance with various import regulations, including Foreign Supplier Verification Program (FSVP) for food, and Prior Notice submissions. For medical devices, they clarify regulatory classifications and assist with establishment registration and premarket notifications. For cosmetics, they address facility registration and product listing requirements. For drugs, they guide through establishment registration, drug listing, and adherence to Good Manufacturing Practices (GMPs). FDA Specialist is committed to helping businesses understand and meet FDA requirements, ensuring smooth market entry and ongoing compliance. They offer free consultations to discuss specific needs and provide tailored solutions for businesses dealing with FDA-regulated products.
About
**Who they are**
FDA Specialist provides comprehensive regulatory compliance services for companies importing food, dietary supplements, cosmetics, medical devices, and drugs into the United States. They focus on ensuring adherence to FDA regulations.
**Expertise & scope**
* **Food Compliance:** Services include facility registration, US Agent representation for foreign facilities, Foreign Supplier Verification Program (FSVP) compliance, low-acid canned food (LACF) and acidified food regulations, prior notice, and label requirements.
* **Medical Device Compliance:** Support covers regulatory classification, establishment registration, US Agent services, device listing, and premarket notification (510k) and approval processes.
* **Cosmetic Compliance:** Assistance includes cosmetic facility registration, product listing, ingredient and product safety, and navigating requirements under the Modernization of Cosmetics Regulation Act (MoCRA).
* **Drug Compliance:** Services encompass establishment registration, drug listing, Good Manufacturing Practices (GMPs), and labeling compliance for Over-The-Counter (OTC) and homeopathic drugs.
* **Import Alerts & Detentions:** Expertise in understanding FDA Import Alerts, petitioning to be removed from the Red List, and managing import detentions and releases, including detention without physical exam (DWPE).
**Reputation / proof points**
* Led by Richard Chiang, Owner and Chief Consultant.
* Services are comprehensive, covering facility registration, US Agent representation, product listings, label reviews, FSVP compliance, and import hold/detention resolution.
FDA Specialist provides comprehensive regulatory compliance services for companies importing food, dietary supplements, cosmetics, medical devices, and drugs into the United States. They focus on ensuring adherence to FDA regulations.
**Expertise & scope**
* **Food Compliance:** Services include facility registration, US Agent representation for foreign facilities, Foreign Supplier Verification Program (FSVP) compliance, low-acid canned food (LACF) and acidified food regulations, prior notice, and label requirements.
* **Medical Device Compliance:** Support covers regulatory classification, establishment registration, US Agent services, device listing, and premarket notification (510k) and approval processes.
* **Cosmetic Compliance:** Assistance includes cosmetic facility registration, product listing, ingredient and product safety, and navigating requirements under the Modernization of Cosmetics Regulation Act (MoCRA).
* **Drug Compliance:** Services encompass establishment registration, drug listing, Good Manufacturing Practices (GMPs), and labeling compliance for Over-The-Counter (OTC) and homeopathic drugs.
* **Import Alerts & Detentions:** Expertise in understanding FDA Import Alerts, petitioning to be removed from the Red List, and managing import detentions and releases, including detention without physical exam (DWPE).
**Reputation / proof points**
* Led by Richard Chiang, Owner and Chief Consultant.
* Services are comprehensive, covering facility registration, US Agent representation, product listings, label reviews, FSVP compliance, and import hold/detention resolution.
Additional information
FDA Specialist assists businesses in navigating complex FDA regulations for imported products. They emphasize proactive compliance to avoid issues like import detentions and alerts. For food importers, understanding and implementing the Foreign Supplier Verification Program (FSVP) is crucial, requiring qualified individuals to assess hazards and verify supplier compliance. For medical devices, correct classification (Class I, II, or III) dictates the regulatory pathway, whether it's a 510(k) submission or premarket approval. Cosmetic companies must be aware of new requirements under MoCRA, including facility registration and product listing. For drugs, accurate establishment registration and drug listing with NDC codes are essential for market entry. Their services aim to streamline these processes, helping clients avoid costly delays and regulatory actions.
Key Highlights
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Provides comprehensive FDA regulatory compliance services for foods, dietary supplements, cosmetics, medical devices, and drugs.
Source
“FDASpecialist provides comprehensive FDA regulatory compliance services for foods, dietary supplements, cosmetics, medical devices, and drugs.”
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Offers US Agent services for foreign facilities, acting as a communication link with the FDA.
Source
“A registered facility in a foreign country must have a US agent. The US agent must be located in the US and receive communications from FDA”
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Specializes in resolving import detentions and petitioning to be removed from FDA Import Alerts.
Source
“For a company to have its products removed from the Red List of an Import Alert, the company must submit a petition to FDA”
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Expertise includes Foreign Supplier Verification Program (FSVP) compliance for imported foods.
Source
“FDA is now enforcing the FSVP rule which requires food importers to maintain documentation and records verifying that the foods they import meet US food-safety standards.”
Certifications & Trust Signals
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Led by Richard Chiang, Owner and Chief Consultant.
Source
“Led by Richard Chiang, Owner and Chief Consultant.”
Buyer Snapshot
Best for
- Foreign companies seeking to import regulated products into the US.
- Businesses needing US Agent representation.
- Companies facing import alerts or detentions.
How engagement typically works
- Consultative approach to identify specific needs.
- Focus on comprehensive regulatory guidance.
Typical deliverables
- FDA facility registrations.
- US Agent appointments.
- FSVP documentation support.
- Import alert resolution strategies.
Good to know
- Best when clients require specialized FDA regulatory expertise for imported goods.
HQ:
Long Beach, US
Languages:
English
Timezones:
America/New_York, America/Chicago, America/Denver, America/Los_Angeles
Claim status:
Listed
Services & Capabilities
Best FDA US Agent Services | Compare & Get Quotes
Jurisdictions:
US
Countries:
US
Industries:
Foods, Beverages
Portfolio:
1-5
Onboarding time:
1–10 days
Pricing model:
Custom pricing
Starting from:
USD 299
Included services:
FDA communications handling, Inspection scheduling coordination, Registration support, Annual renewal reminders
Service Types:
US Agent Services, Food Facility Registration, US Agent Services (Food, Cosmetics, Medical Devices, Drugs), DUNS Application, Label Review (Food, Cosmetics, Medical Devices, Drugs), FSVP (Foreign Supplier Verification Program), APHIS VS Permit Application, Food Canning Establishment (FCE) and SID Filing, Cosmetic Facility Registration, Cosmetic Product Listing, Medical Device Establishment Registration, Device Listing, 510(k) Application Support, Regulatory Evaluation, Drug Establishment Registration, Drug Listing (NDC), Import Hold/Detention Resolution, Import Alert Petitioning, Regulatory Starter Blueprint, FDA Registration/Listing Support, Inspection Support, Label Review, FDA Submissions (510(k), PMA, IDE, etc.), Product/Device Listing, Import Alert/Detention Resolution
Specialties:
Foods and Dietary Supplements, Cosmetics, Medical Devices, Drugs
Pricing:
food: [object Object] • cosmetics: [object Object] • medicalDevices: [object Object] • drugs: [object Object] • general: [object Object]
Turnaround Times:
foodFacilityRegistration: 5 business days • dunsApplication: 5 business days (submission), D&B may take 5+ business days • labelReview: 10 business days (up to 5 labels) • fsvp: Generally 4 weeks • cosmeticRegistration: 5 business days • cosmeticListing: Varies by volume • cosmeticLabelReview: 10 business days (up to 20 labels) • medicalDeviceRegistration: 5 business days
Notes:
All label review services include one re-review after changes at no additional charge. If FDA objects to a label after service (e.g., detention), FDASpecialist will represent client before FDA for no additional charge if all recommended changes were made and product not on Import Alert. Contact info@fdaspecialist.com for RFQs. Owner: Richard Chiang (richard@fdaspecialist.com, 562-882-4981).
510k_submission_services
Jurisdictions:
US
Countries:
US
Industries:
Medical devices
Portfolio:
1-5, 6-25, 26-100, 100+
Onboarding time:
1–14 days
Pricing model:
Per project
Included services:
510(k) submission (premarket notification for class II medical devices), Medical device label review for FDA compliance, Regulatory review for medical devices
Services Offered:
Device Classification Support, 510(k) Strategy & Authoring, Traditional 510(k) Support, Labeling Review for Submission (510(k)/De Novo/PMA)
Pathways Supported:
Traditional 510(k)
Device Types Supported:
Medical device
Supports Estar:
Yes
Supports Rta Remediation:
No
Supports Predicate Research:
No
Supports Labeling Review:
Yes
Provides Submission Project Management:
No
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
Requires understanding of product classification, facility details, and relevant regulatory requirements for specific services like registration or listing.
Coverage Details
U.S.-based agent coverage with defined business-hours availability and escalation path (seed summary).
Product Types
Foods, Dietary Supplements, Cosmetics, Medical Devices, Drugs
Registration Support
Yes, for food facilities, drug establishments, and cosmetic facilities.
Inspection Support
Assists FDA with scheduling inspections of foreign facilities (as US Agent).
US Entity State
US
Recall Support
No
Emergency Contact24x7
No
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