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Drugs

The U.S. Food and Drug Administration (FDA) regulates drug products intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and intended to affect the structure or any function of the body of humans or animals. Registrar Corp provides Registration, U.S. Agent, and Compliance Assistance for U.S. and Non-U.S. Companies in the Drug Industry.

U.S. FDA Drug Establishment Registration and Listings

Owners or operators of all U.S. and non-U.S. drug establishments that engage in the manufacture, preparation, propagation, compounding, or processing of drugs are required to register and submit a list of every drug in commercial distribution in the United States.

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U.S. FDA Drug Establishment Registration and Listing Verification

Between October and December of 2017, drug establishments were required to renew their FDA registration and submit a “blanket no-change” certification for all drug listings that received no changes within the year. Registrar Corp can verify whether your drug establishment registration and listings are valid at no cost.

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Drug Labeling and Ingredient Reviews

FDA requires that drug labels be indexed using Extensible Markup Language (XML) in Structured Product Labeling (SPL) format. Registrar Corp can help modify your drug labeling to comply with FDA regulations. Registrar Corp provides revised graphic files ready to be printed or edited, and a report that details the regulations, compliance guides, warning letters, import alerts, and other guidance documents from FDA.

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U.S. FDA Drug Master Files (DMF)

A Drug Master File is a submission to FDA that may be used in support of pre-market submissions to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more drugs. Registrar Corp’s team of Regulatory Specialists provide guidance as to required elements, formats, and particularities of Drug Master File submissions.

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U.S. FDA Adverse Event Contact for OTC Drugs

U.S. FDA requires labels of OTC drugs marketed without an approved application to bear a United States address or phone number to receive consumer reports of serious adverse events. Registrar Corp can serve as your U.S. Contact for the timely forwarding of consumer reports to your business as required by FDA.

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U.S. FDA Outsourcing Facility Regulations

Compounding Pharmacies that register with FDA as Outsourcing Facilities may qualify for exemption from certain FDA approval and labeling requirements. Registrar Corp’s Regulatory Specialists can register pharmacies as Outsourcing Facilities as well as help them comply with FDA’s regulations for doing so, including submission of annual drug product reports.

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U.S. FDA Self-Identification Requirements for Generic Drug Facilities

Operators of facilities that produce generic drugs and generic drug APIs must submit “self-identification” information to FDA between May 1 and June 1 of each year.

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Data Universal Numbering System (D-U-N-S®)

The Data Universal Numbering System (D-U-N-S®) is a business identification system operated by the private company Dun & Bradstreet®. D-U-N-S® numbers are required for drug establishments to register and list products with FDA.

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U.S. FDA 3PL/WDD Reporting

Third-party Logistics (3PL) and Wholesale Drug Distributors (WDD) must report to FDA between January 1 and March 31 of each year.

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U.S. FDA Drug Color Additives and Drug Color Batch Certification

A drug color additive is any dye, pigment, or other substance that can impart color to a drug product. Drug color additives are regulated by FDA.

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Certificate of U.S. FDA Registration issued by Registrar Corp

Companies registered with FDA often are asked by their customers and suppliers to verify their FDA registrations. A Certificate of Registration issued by Registrar Corp serves as a third-party verification of your FDA registration.

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Detention Without Physical Examination ("DWPE") Assistance

Companies shipping products to the United States may find their shipments subject to Detention Without Physical Examination (“DWPE”) by FDA. Products subject to DWPE are held at the port of entry while FDA performs additional scrutiny, testing, and analysis. Delays from DWPE may be lengthy for businesses anxious to deliver products on schedule.

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Registrar Corp's FDA Registration Service

When you designate Registrar Corp to renew your FDA registration, you receive year-round benefits at no additional cost, including:

- Registration renewal and updates as required
- U.S. Agent for FDA Communications (Required for Non-US Facilities)
- Qualified Facility Attestation Guidance
- Certificate of Registration issued by Registrar Corp
- Three free Prior Notice filings each year
- Detention Assistance
- DUNS Assistance
- Mock FDA Inspection: Onsite expert assistance at a discounted rate
- FDA Compliance Monitoring for your facility


Registrar Corp's Registration Service

Registrar Corp's Registration service includes:
  • Certificate of Registration Issued by Registrar Corp: Provides confirmation of your facility’s registration to industry
  • Registration Updates for the Current Year: Registrations must be updated within 60 days of a change in required information
  • Prior Notice: Three free Prior Notice filings each year for products you may import
  • Detention Assistance: Communication with FDA on your behalf to seek the release of a detained shipment
  • DUNS Assistance: Obtain a DUNS number or update an existing DUNS record
  • FDA Compliance Monitoring: A unique system that continuously monitors your company’s FDA compliance status.



U.S. FDA Food Facility Registration Certificate

U.S. Food Facility Registration Certificate


FDA Registration and U.S. Agent Fees

‌US Food Facility Registration:$195 (Includes Certificate)
Non-US Food Facility Registration and U.S. Agent: $695 (Includes Certificate)
‌Certificate Only: $195



Prior Notice Fees

$19.95 per shipment

Discounts available for multiple shipments.



Labeling and Ingredient Review Fees

Labeling Review: $1,495 per product
Label Creation: $1,995 per product

Discounts available for multiple products.



Food Canning Establishment (FCE) and Process Filings (SID) Fees

FCE-SID Filing Service (First Year): $1,995
FCE-SID Filing Service (Annual Renewal): $995
FCE-SID Exclusion Certificate: $399 per product



Shell Egg Registration Fee

Shell Egg Registration: $195


FDA Dairy List Fee

Dairy List Petition: $1495



Certificate of Registration Fee

Certificate of FDA Registration: $195



Food Contact Substances (FCS) Fee

Food Contact Substance Review: $1,495 per product



Color Additive and Color Batch Certification Fees

Color Additive Report: $395 per color
Color Batch Certification Filing: $395 per batch



Data Universal Numbering System (DUNS)

Registrar Corp can obtain a Data Universal Numbering System
(DUNS) Number for your facility at no cost.



U.S. FDA Medical Device Establishment Registration Certificate

U.S. Food Facility Registration Certificate


FDA Registration and Listing Fees

FDA Device Establishment Registration: $150
Medical Device FDA Agent (includes Official Correspondent, U.S. Agent, GUDID Regulatory Contact, and eMDR Authorizing Official): $995 (Annual Fee)
Device Listings: $195 per product code



Labeling and Product Review Fees

Labeling or Product Review: $1,495 per product
Label Creation: $1,995 per product

Discounts available for multiple products.



Electronic Medical Device Reporting (eMDR) Fees

Registrar Corp submits adverse event reports for Official Correspondent and U.S. Agent Clients at no cost.



U.S. FDA Drug Establishment Registration Certificate

U.S. Food Facility Registration Certificate


Unique Device Identifier (UDI) Submission Fees

Single Submission: $95
Block of 10: $495 ($49.50 per submission)
Block of 25: $995 ($39.80 per submission)
Block of 50: $1,495 ($29.90 per submission)
Block of 100: $1,990 ($19.90 per submission)
Block of 500: $7,250 ($14.50 per submission)
Block of 1000: $9,950 ($9.95 per submission)



Medical Device Master File (MAF) Fees

MAF Submission: $1,495
MAF Agent for FDA Communications: $995 (Annual Fee)



Drug Master File (DMF) Fees

DMF Submission (CTD to eCTD): $1,995
For non-CTD submissions, Contact Registrar Corp
DMF Agent for FDA Communications: $995 (Annual Fee)



3PL/WDD Reporting Fees

3PL/WDD Reporting: $995 (Annual Fee)



FDA Registration and Listing Fees

FDA Drug Establishment Registration: $845
Registrant Contact and U.S. Agent: $995 (Annual Fee)
Drug Listings: $645 per listing



Self-Identification Fee

Self-Identification Submission: $995

Registrar Corp submits self-identification information to FDA for Registrant Contact and U.S. Agent Clients at no cost.



Outsourcing Facility Fee

Registration and Registrant Contact: $1995



Adverse Event Contact Fee

U.S. Adverse Event Contact for OTC Labels: $500



Export Certificate Fees

Export Certificate: $195



Radiation-Emitting Electronic Device Registration

Initial Product Report: $995
Annual Report: $495
Abbreviated Report: $995
Supplemental Report: $395
Agent for FDA Communications: $695



California Safe Cosmetics Act Certificate


Cosmetic Registration and Filing Fees

Cosmetic Registration: $395

Single Filing: $695
Block of 10: $3950 ($395 per filing)
Block of 25: $5,625 ($225 per filing)
Block of 50: $6,250 ($125 per filing)
Block of 100: $7,500 ($75 per filing)

Discounts available when filing with both
FDA and the State of California.



Cosmetic/Drug Registration Fee

Cosmetic/Drug Registration: $845
Registrant Contact and U.S. Agent: $995 (Annual Fee)
Cosmetic/Drug Listings: $645 per listing



Detention Assistance

Registrar Corp's fee for detention assistance is dependent on the cause of detention. Please call for a quote.



Fees for Food Safety Services

Food Safety Plan (First Product): $1995
Food Safety Plan (Additional Products): $995
HACCP Plan Review: $1995
HACCP Plan Creation: $1995
Foreign Supplier Verification Program: $1995
Foreign Supplier Verification Program (Additional Products): $995
Foreign Supplier Verification Program Agent: Price varies by location. Contact Registrar Corp
Voluntary Qualified Importer Program: Contact Registrar Corp
Food Defense Plan: $1995
Mock FDA Inspection: Contact Registrar Corp



Tobacco Registration and Listing Fees

Authorized Agent: $495
Tobacco Facility Registration: $195

Single Listing: $195
Block of 10: $1,750 ($175 per listing)
Block of 25: $3,750 ($150 per listing)
Block of 50: $6,250 ($125 per listing)
Block of 100: $9,500 ($95 per listing)



U.S. Adverse Event Contact for OTC Labels

U.S. Adverse Event Contact for OTC Labels: $500



U.S. Adverse Event Contact for Dietary Supplement Labels

U.S. Adverse Event Contact for Dietary Supplement Labels: $500



TOBACCO PRODUCT LABELING REVIEW Fee

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