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FDA Registration and U.S. Agent
Registrar Corp's U.S. Agent and Registration Services Include:
- FDA Registration and Renewal
- Access to MyFDA.com
- Free Registration Updates
- 3 Free Prior Notice Filings per year
- FDA Compliance Monitoring of your facility
- Certificate of FDA Registration issued by Registrar Corp
- Mock FDA Inspection
- DUNS Assistance
- Non-U.S. Food Facility Registration and U.S. Agent$695 (Includes Certificate)
- U.S. Food Facility Registration$195 (Includes Certificate)
- Certificate of Registration$195
Prior Notice Express
File Prior Notice with FDA quickly and properly. Create and store autofill information to save time and reduce filing errors.
- 1 Prior Notice Filing$19.95
- 10 Prior Notice Filings$17.95 each
- 25 Prior Notice Filings$14.95 each
- 50 Prior Notice Filings$12.95 each
- 100 Prior Notice Filings$9.95 each
Discounts available for multiple shipments
Get StartedLabeling and Ingredient Review
Registrar Corp’s Regulatory Specialists can update your label for compliance with FDA’s new rules.
- Labeling ReviewFree Assessment
Discounts available for multiple products
Get StartedFood Canning Establishment (FCE) and Process Filings (SID) Regulations
Registrar Corp FCE-SID experts provide multi-lingual compliance support for FCE facilities, including:
- Assistance with the FCE registration process, including accessing FDA’s online LACF system
- Guidance as to required elements, formats, and particularities of FCE-SID submissions
- FCE-SID Certificates issued by Registrar Corp documenting your valid SID listings to assure your customers that your products have been properly filed with U.S. FDA
- FCE-SID Filing Service (First Year)$1995
- FCE-SID Filing Service (Annual Renewal)$995
- FCE-SID Exclusion Certificate$399 per product
Food Safety Plans and Programs
Registrar Corp’s team of Food Safety Specialists assists food and beverage facilities to comply with FDA food safety regulations.
- Hazard Analysis and Risk-Based Preventive Control (HARPC) Plan$1995 2-5 products are $1,495 per product
5-10 products are $1,295 per product - Hazard Analysis and Critical Control Points (HACCP) Plan$1995 (additional products) $995
- Foreign Supplier Verification Program (FSVP)$1995 (additional products) $995
- Foreign Supplier Verification Program (FSVP)$1995 (additional products) $995
- Juice Importer Verification ProgramStarting at $1995
- Seafood Importer Verification ProgramStarting at $1995
- Mock FDA Food Facility InspectionPrice varies by location.
- Recall Plan$395
- Food Defense Plan$1995
Food Contact Substance
The determination of how a particular food contact substance is regulated by FDA depends on its chemical composition and intended uses. Registrar Corp’s team of Regulatory Specialists help manufacturers identify the specifications and limitations published and enforced by FDA concerning their specific products.
- Food Contact Substance Review$1495 per product
FDA Export Listing Module
Registrar Corp can properly petition to have your facility included on an FDA export list through FDA’s Export Listing Module.
- ELM PetitionContact Registrar Corp for Pricing
Certificate of U.S. FDA Registration Issued by Registrar Corp
A Certificate of Registration issued by Registrar Corp serves as a third-party verification of your FDA food facility registration.
- Certificate of Registration$195
Guide to U.S. Wine Label Regulations
The Alcohol and Tobacco Tax and Trade Bureau (TTB) regulates wine with an alcohol content of 7% or more, and the labeling of these wines must be approved by TTB before marketing. Registrar Corp’s wine labeling guide will arm you with the knowledge you need to develop a compliant wine label.
- Wine Labeling Guide$195
State Bottled Water Requirements
Many U.S. states require licensing, certification, or additional labeling statements for bottled water sold in their jurisdiction in additon to FDA regulations. Registrar Corp offers reports that explain the different requirements for each state.
- State Bottled Water Guide$695
FDA Compliance Monitor
Automate supply-chain risk management. Monitor the compliance status and history of any FDA-regulated company
- Block of 5 Facilities$58 per month (Billed Annually)
- Block of 10 Facilities$110 per month (Billed Annually)
- Block of 15 Facilities$162 per month (Billed Annually)
- Block of 25 Facilities$265 per month (Billed Annually)
- Block of 50 Facilities$516 per month (Billed Annually)
- Block of 100 Facilities$1010 per month (Billed Annually)
Color Additive and Color Batch Certification
Registrar Corp helps companies comply with U.S. FDA’s extensive Color Additive requirements by cross referencing your color against thousands of pages within the Code of Federal Regulations as well as the Federal Register, EAFUS Database, Labeling Guides, and Warning Letters issued by U.S. FDA.
- Color Additive Report$395 per color
- Color Batch Certification Filing$395 per batch
Detention Assistance
Registrar Corp works with companies to clarify the causes of detentions and helps to solve the problem whenever possible so that the product may quickly move to its final destination.
Registrar Corp's fee for detention assistance is dependent on the cause of detention. Contact Registrar Corp for pricing.
Get StartedExport Certificate to Foreign Governments
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply an “Export Certificate” for products regulated by FDA. An Export Certificate is a document prepared by FDA containing information about a product’s regulatory or marketing status.
- Export Certificate$195
FDA charges additional fees based on the type of certificate
Get StartedMedical Devices
FDA Registration and Listing
Registrar Corp's U.S. Agent and Official Correspondent Services Include:
- FDA Registration and Renewal
- Certificate of Registration issued by Registrar Corp
- Registration Updates
- UDI Regulatory Contact
- Electronic Medical Device Reporting (eMDR)
- Detention Assistance
- FDA Compliance Monitoring of your facility
- Medical Device FDA Agent$995 (Annual Fee)
Includes Official Correspondent, U.S. Agent, GUDID Regulatory Contact, and eMDR Authorizing Official - Certificate of Registration$195
- Device Listings$195 per product code
Discounts available for multiple listings.
Get StartedGlobal Unique Device Identification Database(GUDID) Submissions
Registrar Corp offers simple, low-cost solutions for FDA UDI and GUDID requirements.
- Single Submission$95
- Block of 10$495
- Block of 25$995
- Block of 50$1495
- Block of 100$1990
- Block of 500$7250
- Block of 1000$9950
Labeling and Product Review
Registrar Corp helps companies determine their devices likely classification and applicable labeling requirements.
- Labeling ReviewFree Assessment
Discounts available for multiple products.
Get StartedMedical Device Master File (MAF) Submissions
Registrar Corp assists with Master File requirements. Our Regulatory Specialists can:
- File a new DMF, MAF, or VMF
- Update or Amend an MF
- Convert a paper DMF to eCTD
- MAF Submission$1495
- MAF Agent for FDA Communications$995 (Annual Fee)
Certificate of U.S. FDA Registration Issued by Registrar Corp
A Certificate of Registration issued by Registrar Corp serves as a third-party verification of your FDA food facility registration.
- Certificate of Registration$195
FDA Compliance Monitor
Automate supply-chain risk management. Monitor the compliance status and history of any FDA-regulated company
- Block of 5 Facilities$58 per month (Billed Annually)
- Block of 10 Facilities$110 per month (Billed Annually)
- Block of 15 Facilities$162 per month (Billed Annually)
- Block of 25 Facilities$265 per month (Billed Annually)
- Block of 50 Facilities$516 per month (Billed Annually)
- Block of 100 Facilities$1010 per month (Billed Annually)
Color Additive and Color Batch Certification
Registrar Corp helps companies comply with U.S. FDA’s extensive Color Additive requirements by cross referencing your color against thousands of pages within the Code of Federal Regulations as well as the Federal Register, EAFUS Database, Labeling Guides, and Warning Letters issued by U.S. FDA.
- Color Additive Report$395 per color
- Color Batch Certification Filing$395 per batch
Detention Assistance
Registrar Corp works with companies to clarify the causes of detentions and helps to solve the problem whenever possible so that the product may quickly move to its final destination.
Registrar Corp's fee for detention assistance is dependent on the cause of detention. Contact Registrar Corp for pricing.
Get StartedExport Certificate to Foreign Governments
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply an “Export Certificate” for products regulated by FDA. An Export Certificate is a document prepared by FDA containing information about a product’s regulatory or marketing status.
- Export Certificate$195
FDA charges additional fees based on the type of certificate
Get StartedDrugs
FDA Registration and Listing
Registrar Corp's U.S. Agent and Registrant Contact Services Include:
- FDA Registration and Renewal
- Certificate of Registration issued by Registrar Corp
- Annual Listing Certification
- Registration and Listing Updates
- Labeler Code Assistance
- Detention Assistance
- DUNS Assistance
- FDA Compliance Monitoring of your facility
- FDA Drug Establishment Registration$995 (Includes Certificate)
- Registrant Contact and U.S. Agent$995 (Annual Fee)
- Certificate of Registration$195
- Drug Listings$695 per listing
Discounts available for multiple listings.
Get StartedLabeling and Ingredient Review
Registrar Corp’s Drug Labeling and Ingredient Review service helps companies determine their drug’s likely classification and compliance with applicable labeling requirements.
- Labeling and Ingredient ReviewFree Assessment
Discounts available for multiple products.
Get StartedDrug Master File (DMF) Submissions
Registrar Corp assists with Master File requirements. Our Regulatory Specialists can:
- File a new DMF, MAF, or VMF
- Update or Amend an MF
- Convert a paper DMF to eCTD
- DMF Submission (CTD to eCTD)$1995
- Non-CTD SubmissionContact Registrar Corp for pricing
- DMF Agent for FDA Communications$1995 (Annual Fee)
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.
- U.S. Adverse Event Contact for OTC Labels$500
Certificate of U.S. FDA Registration Issued by Registrar Corp
A Certificate of Registration issued by Registrar Corp serves as a third-party verification of your FDA food facility registration.
- Certificate of Registration$195
Outsourcing Facilities
Registrar Corp can serve as Registrant Contact for your Outsourcing Facility.
- Registration and Registrant Contact$1995
FDA Compliance Monitor
Automate supply-chain risk management. Monitor the compliance status and history of any FDA-regulated company
- Block of 5 Facilities$58 per month (Billed Annually)
- Block of 10 Facilities$110 per month (Billed Annually)
- Block of 15 Facilities$162 per month (Billed Annually)
- Block of 25 Facilities$265 per month (Billed Annually)
- Block of 50 Facilities$516 per month (Billed Annually)
- Block of 100 Facilities$1010 per month (Billed Annually)
Color Additive and Color Batch Certification
Registrar Corp helps companies comply with U.S. FDA’s extensive Color Additive requirements by cross referencing your color against thousands of pages within the Code of Federal Regulations as well as the Federal Register, EAFUS Database, Labeling Guides, and Warning Letters issued by U.S. FDA.
- Color Additive Report$395 per color
- Color Batch Certification Filing$395 per batch
Detention Assistance
Registrar Corp works with companies to clarify the causes of detentions and helps to solve the problem whenever possible so that the product may quickly move to its final destination.
Registrar Corp's fee for detention assistance is dependent on the cause of detention. Contact Registrar Corp for pricing.
Get StartedExport Certificate to Foreign Governments
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply an “Export Certificate” for products regulated by FDA. An Export Certificate is a document prepared by FDA containing information about a product’s regulatory or marketing status.
- Export Certificate$195
FDA charges additional fees based on the type of certificate
Get StartedCosmetics
FDA Registration
Registrar Corp can assist you with FDA’s Voluntary Cosmetic Registration Program (VCRP).
- Cosmetic Registration$395 (Includes Certificate)
- Certificate of Registration$195
Cosmetic Filings (FDA or California)
Registrar Corp helps companies determine which ingredients in their products may be subject to the California Safe Cosmetics Act and reports them to California.
- Single Filing$695
- Block of 10$3950
- Block of 25$5625
- Block of 50$6250
- Block of 100$7500
Discounts available when filing with both FDA and the State of California.
Get StartedLabeling and Ingredient Review
Registrar Corp’s labeling experts can review current labels, and redesign cosmetic labeling to comply with U.S. 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 the U.S. FDA.
- Labeling ReviewFree Assessment
Discounts available for multiple products.
Get StartedCertificate of U.S. FDA Registration Issued by Registrar Corp
A Certificate of Registration issued by Registrar Corp serves as a third-party verification of your FDA food facility registration.
- Certificate of Registration$195
FDA Compliance Monitor
Automate supply-chain risk management. Monitor the compliance status and history of any FDA-regulated company
- Block of 5 Facilities$58 per month (Billed Annually)
- Block of 10 Facilities$110 per month (Billed Annually)
- Block of 15 Facilities$162 per month (Billed Annually)
- Block of 25 Facilities$265 per month (Billed Annually)
- Block of 50 Facilities$516 per month (Billed Annually)
- Block of 100 Facilities$1010 per month (Billed Annually)
Color Additive and Color Batch Certification
Registrar Corp helps companies comply with U.S. FDA’s extensive Color Additive requirements by cross referencing your color against thousands of pages within the Code of Federal Regulations as well as the Federal Register, EAFUS Database, Labeling Guides, and Warning Letters issued by U.S. FDA.
- Color Additive Report$395 per color
- Color Batch Certification Filing$395 per batch
Detention Assistance
Registrar Corp works with companies to clarify the causes of detentions and helps to solve the problem whenever possible so that the product may quickly move to its final destination.
Registrar Corp's fee for detention assistance is dependent on the cause of detention. Contact Registrar Corp for pricing.
Get StartedExport Certificate to Foreign Governments
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply an “Export Certificate” for products regulated by FDA. An Export Certificate is a document prepared by FDA containing information about a product’s regulatory or marketing status.
- Export Certificate$195
FDA charges additional fees based on the type of certificate
Get StartedDietary Supplements
FDA Registration and U.S. Agent
Registrar Corp's U.S. Agent and Registration Services Include:
- FDA Registration and Renewal
- Access to MyFDA.com
- Free Registration Updates
- 3 Free Prior Notice Filings per year
- FDA Compliance Monitoring of your facility
- Certificate of FDA Registration issued by Registrar Corp
- Mock FDA Inspection
- DUNS Assistance
- Non-U.S. Food Facility Registration and U.S. Agent$695 (Includes Certificate)
- U.S. Food Facility Registration$195 (Includes Certificate)
- Certificate of Registration$195
Prior Notice Express
File Prior Notice with FDA quickly and properly. Create and store autofill information to save time and reduce filing errors.
- 1 Prior Notice Filing$19.95
- 10 Prior Notice Filings$17.95 each
- 25 Prior Notice Filings$14.95 each
- 50 Prior Notice Filings$12.95 each
- 100 Prior Notice Filings$9.95 each
Discounts available for multiple shipments
Get StartedLabeling and Ingredient Review
Registrar Corp’s Regulatory Specialists can update your label for compliance with FDA’s new rules.
- Labeling ReviewFree Assessment
Discounts available for multiple products
Get StartedU.S. FDA Adverse Event Contact
Registrar Corp can serve as your U.S. Contact for the timely forwarding of consumer reports to your business as required by FDA.
- U.S. Adverse Event Contact for Dietary Supplement Labels$500
Certificate of U.S. FDA Registration Issued by Registrar Corp
A Certificate of Registration issued by Registrar Corp serves as a third-party verification of your FDA food facility registration.
- Certificate of Registration$195
Master Manufacturing Records
Registrar Corp’s Food Safety Specialists can review your Master Manufacturing Record for FDA compliance.
- First Master Manufacturing Record Review$2495
- Additional Master Manufacturing Record Reviews$1495 each
FDA Compliance Monitor
Automate supply-chain risk management. Monitor the compliance status and history of any FDA-regulated company
- Block of 5 Facilities$58 per month (Billed Annually)
- Block of 10 Facilities$110 per month (Billed Annually)
- Block of 15 Facilities$162 per month (Billed Annually)
- Block of 25 Facilities$265 per month (Billed Annually)
- Block of 50 Facilities$516 per month (Billed Annually)
- Block of 100 Facilities$1010 per month (Billed Annually)
Color Additive and Color Batch Certification
Registrar Corp helps companies comply with U.S. FDA’s extensive Color Additive requirements by cross referencing your color against thousands of pages within the Code of Federal Regulations as well as the Federal Register, EAFUS Database, Labeling Guides, and Warning Letters issued by U.S. FDA.
- Color Additive Report$395 per color
- Color Batch Certification Filing$395 per batch
Detention Assistance
Registrar Corp works with companies to clarify the causes of detentions and helps to solve the problem whenever possible so that the product may quickly move to its final destination.
Registrar Corp's fee for detention assistance is dependent on the cause of detention. Contact Registrar Corp for pricing.
Get StartedExport Certificate to Foreign Governments
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply an “Export Certificate” for products regulated by FDA. An Export Certificate is a document prepared by FDA containing information about a product’s regulatory or marketing status.
- Export Certificate$195
FDA charges additional fees based on the type of certificate
Get StartedOther
Radiation-Emitting Electronic Device Reporting
Registrar Corp can serve as your U.S. Agent for service of process and assist with submission of Product Reports, if required
- Initial Product Report$995
- Annual Report$495
- Abbreviated Report$995
- Supplemental Report$395
- Agent for FDA Communications$695
RED Labeling and Product Review
Registrar Corp helps companies determine whether their products may be considered a Radiation-Emitting Electronic Device by FDA. For products that are likely considered a Radiation-Emitting Electronic Device, Registrar Corp provides guidance regarding applicable FDA labeling requirements and performance standards, as well as other FDA regulations.
- Labeling ReviewFree Assessment
Discounts available for multiple products
Get StartedFDA Tobacco Registration and Authorized Agent
Registrar Corp helps tobacco manufacturers comply with FDA Regulations
- Authorized Agent$495
- Tobacco Facility Registration$195
Initial Tobacco Product Listings or Ingredient Listings
Registrar Corp helps tobacco manufacturers comply with FDA Regulations
- Single Submission$195
- Block of 10$1750
- Block of 25$3750
- Block of 50$6250
- Block of 100$9500
FDA Compliance Monitor
Automate supply-chain risk management. Monitor the compliance status and history of any FDA-regulated company
- Block of 5 Facilities$58 per month (Billed Annually)
- Block of 10 Facilities$110 per month (Billed Annually)
- Block of 15 Facilities$162 per month (Billed Annually)
- Block of 25 Facilities$265 per month (Billed Annually)
- Block of 50 Facilities$516 per month (Billed Annually)
- Block of 100 Facilities$1010 per month (Billed Annually)
Color Additive and Color Batch Certification
Registrar Corp helps companies comply with U.S. FDA’s extensive Color Additive requirements by cross referencing your color against thousands of pages within the Code of Federal Regulations as well as the Federal Register, EAFUS Database, Labeling Guides, and Warning Letters issued by U.S. FDA.
- Color Additive Report$395 per color
- Color Batch Certification Filing$395 per batch
Detention Assistance
Registrar Corp works with companies to clarify the causes of detentions and helps to solve the problem whenever possible so that the product may quickly move to its final destination.
Registrar Corp's fee for detention assistance is dependent on the cause of detention. Contact Registrar Corp for pricing.
Get StartedExport Certificate to Foreign Governments
Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply an “Export Certificate” for products regulated by FDA. An Export Certificate is a document prepared by FDA containing information about a product’s regulatory or marketing status.
- Export Certificate$195
FDA charges additional fees based on the type of certificate
Get Started