FDA Essentials

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SID Filing
(LACF / Acidified)

Let us handle your Low Acid Food process filings. Scheduled processes are used by canning establishments in the manufacture and processing of ...

Modify PPQ Permit

Let us make changes to your existing PPQ Permit. A PPQ Permit is required for plant produc ...

$199

Modify VS Permit

Let us make changes to your existing VS permit. A VS Permit is required for animal product ...

$279

VS Permit (Renewal)

Let us renew your VS Permit. A VS Permit is required for animal products that could potent ...

$299

PPQ Permit (Renewal)

Let us renew your PPQ Permit. A PPQ Permit is required for plant products that could poten ...

$199

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

Food Label Review

Get an expert review for FDA labeling compliance. Our comprehensive review is aimed at ass ...

$749

Nutrition Facts

Get a custom built Nutrition Facts panel. Our nutrition facts panel creation service is a ...

$99

Food Claims Review

Get an expert review of all your claims for FDA and FTC compliance. Claims are a key target for FDA and FTC enforcement. Our evaluation can as ...

Food Facility Registration & U.S. Agent Service

Use our registration tool to easily register today! To enter the US market, every food man ...

$199

Foreign Supplier Verification Program (FSVP) Plan

Build a Foreign Supplier Verification Plan (FSVP) with us today! FSVP stands for Foreign S ...

$1499

Food Ingredient Review

Get an expert ingredient review of all your food ingredients for FDA and FTC compliance.

FDA Import Hold / Detention Resolution

Get expert assistance today. Get help for your detained shipment today. If it is possible, we can help you get your shipment released. Let our ...

Warning Letter Resolution

We will help you identify all the regulatory issues, help you resolve them, and draft a response to FDA to help you close out your Warning Let ...

Import Alert Resolution

We will help you develop a corrective action plan and create a petition for removal from Import Alert Our team of experts will help you develo ...

Food Safety Plan

Get a Food Safety Plan Review. Our team of food safety experts can evaluate your company's ...

$899

Recall Plan

Get a custom Recall Plan. Our FDA Recall Plan service provides you with a comprehensive se ...

$499

Food Defense Plan

Get a custom Food Defense Plan. Our service offers excellent documents and templates that guide you in creating your own FDA Food Defense Plan ...

VS Permit

Get your VS Permit here! A VS Permit is required for animal products that could potentiall ...

$599

PPQ Permit

Get your PPQ, CITES, or FAVIR permit here. A PPQ Permit is required for plant products tha ...

$599

Emergency Permit / On-Hold Shipment

Get an Emergency Permit (On-Hold Shipment) to resolve your EAN. Let us help you get an eme ...

$1999

Food Regulatory Review

Get an evaluation of your product's FDA requirements. Our regulatory review will provide a ...

$349

Low Acid Canned Food / Acidified Food Establishment Registration

Let us submit your registration. If you produce low-acid foods, you need to register as a food canning establishment (FCE) with the FDA. This ...

Facility Inspection Assistance

We will help you during the inspection and help you draft answers to FDA's objections and observations. Get expert help responding to an FDA I ...

Food Facility Registration Renewal

Let us renew your facility registration. It's critical to renew the registration of your f ...

$99

U.S. Agent Service

The FDA mandates that non-US food companies designate a US Agent for registration. As part ...

$99 per year

FDA Export Certificates

Get your export certificates. Call us if you need Apostilles.

$249

Export FDA Unapproved Products

Our experts will guide and consult with you through the requirements for exporting products not approved in the US. We evaluate your products ...

Untitled Letters

We will help you identify all the regulatory issues, help you resolve your Untitled Letter, by responding to FDA to help you close out your Un ...

Food Defense Plan

Get a custom Food Defense Plan. Our service offers excellent documents and templates that guide you in creating your own FDA Food Defense Plan ...

Dietary Supplement Label Review

Get an expert review for FDA labeling compliance.

$999

Modify VS Permit

Let us make changes to your existing VS permit. A VS Permit is required for animal product ...

$279

Modify PPQ Permit

Let us make changes to your existing PPQ Permit. A PPQ Permit is required for plant produc ...

$199

PPQ Permit (Renewal)

Let us renew your PPQ Permit. A PPQ Permit is required for plant products that could poten ...

$199

Dietary Supplement Facility Registration Renewal

Let us renew your facility registration. It's critical to renew the registration of your f ...

$99

VS Permit (Renewal)

Let us renew your VS Permit. A VS Permit is required for animal products that could potent ...

$299

Dietary Supplement Claims Review

Get an expert review of all your claims for FDA and FTC compliance.

Supplement Facts Label

Get a custom-built Supplement Facts panel.

$299

Dietary Supplement Facility Registration

Use our registration tool to register your facility.

$199

FSVP for Dietary Supplements

Build a Foreign Supplier Verification Plan (FSVP) with us today!

$1499

Dietary Supplement Ingredient Compliance

Get critical information about the safety and legal status of your dietary ingredients.

Serious Adverse Events Reporting Service

We can set up a dedicated phone line for OTC drugs, Cosmetics, or Dietary Supplement adverse events reporting. We can even receive the reports ...

New Dietary Ingredient Notification

Let us help you prepare a dietary ingredient notification.

FDA Import Hold / Detention Resolution

Get expert assistance today. Get help for your detained shipment today. If it is possible, we can help you get your shipment released. Let our ...

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

Warning Letter Resolution

We will help you identify all the regulatory issues, help you resolve them, and draft a response to FDA to help you close out your Warning Let ...

Dietary Supplement Regulatory Review

Get a supplement evaluation of your product's FDA compliance and an explanation of all you ...

$349

Recall Plan

Get a custom Recall Plan. Our FDA Recall Plan service provides you with a comprehensive se ...

$499

VS Permit

Get your VS Permit here! A VS Permit is required for animal products that could potentiall ...

$599

PPQ Permit

Get your PPQ, CITES, or FAVIR permit here. A PPQ Permit is required for plant products tha ...

$599

Emergency Permit / On-Hold Shipment

Get an Emergency Permit (On-Hold Shipment) to resolve your EAN. Let us help you get an eme ...

$1999

Import Alert Resolution

We will help you develop a corrective action plan and create a petition for removal from Import Alert Our team of experts will help you develo ...

Facility Inspection Assistance

We will help you during the inspection and help you draft answers to FDA's objections and observations. Get expert help responding to an FDA I ...

Courtesy Letter Help

Let us help you understand the effect of FDA’s Courtesy Letter. We will review your claims, change them if needed, and prepare to file a suc ...

U.S. Agent Service

The FDA mandates that non-US food companies designate a US Agent for registration. As part ...

$99 per year

FDA Export Certificates

Get your export certificates. Call us if you need Apostilles.

$249

Dietary Supplement Good Manufacturing Practices (GMPs) Compliance

Get expert consultation on your current GMPs or help building your new GMP plans.

Structure / Function Notification

We will draft and submit your letter for an affordable flat-fee. We will help you avoid pu ...

$199

Export FDA Unapproved Products

Our experts will guide and consult with you through the requirements for exporting products not approved in the US. We evaluate your products ...

Untitled Letters

We will help you identify all the regulatory issues, help you resolve your Untitled Letter, by responding to FDA to help you close out your Un ...

Cosmetic Label Review

Get an expert review for FDA labeling compliance. Our review will tell you everything you ...

$749

Cosmetic Ingredient Review

We will review your ingredients for safety to make sure you comply with MOCRA. Get your ingredients reviewed for safety to make sure you compl ...

Cosmetic Facility Registration

Get your facility registered before MOCRA goes into effect.

$299

Serious Adverse Events Reporting Service

We can set up a dedicated phone line for OTC drugs, Cosmetics, or Dietary Supplement adverse events reporting. We can even receive the reports ...

Cosmetics Good Manufacturing Practices (GMPs) Compliance

Get expert consultation on your current GMPs or help building your new GMP plans ahead of the MOCRA compliance date. Work with experts develop ...

California Safe Cosmetics Filing

We will file your products with California. Buy 5, Get 1 free

$499

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

Warning Letter Resolution

We will help you identify all the regulatory issues, help you resolve them, and draft a response to FDA to help you close out your Warning Let ...

FDA Import Hold / Detention Resolution

Get expert assistance today. Get help for your detained shipment today. If it is possible, we can help you get your shipment released. Let our ...

Import Alert Resolution

We will help you develop a corrective action plan and create a petition for removal from Import Alert Our team of experts will help you develo ...

Facility Inspection Assistance

We will help you during the inspection and help you draft answers to FDA's objections and observations. Get expert help responding to an FDA I ...

U.S. Agent Service

The FDA mandates that non-US food companies designate a US Agent for registration. As part ...

$99 per year

Recall Plan

Get a custom Recall Plan. Our FDA Recall Plan service provides you with a comprehensive se ...

$499

Cosmetic Claims Review

Get an expert review of your claims today!

Cosmetic Product Listing

Get your MOCRA Product Listings. Buy 5, Get 1 free.

$149

FDA Export Certificates

Get your export certificates. Call us if you need Apostilles.

$249

Export FDA Unapproved Products

Our experts will guide and consult with you through the requirements for exporting products not approved in the US. We evaluate your products ...

Untitled Letters

We will help you identify all the regulatory issues, help you resolve your Untitled Letter, by responding to FDA to help you close out your Un ...

Medical Device Facility Registration

Get your facility registered.

$499

510(k) Filing

Get expert help drafting and submitting your 510k.

Medical Device Regulatory Review

We will classify your device and explain all your obligations.

$1499

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

Medical Device Listing

Let us list your products.

$99 each

FDA Import Hold / Detention Resolution

Get expert assistance today. Get help for your detained shipment today. If it is possible, we can help you get your shipment released. Let our ...

Import Alert Resolution

We will help you develop a corrective action plan and create a petition for removal from Import Alert Our team of experts will help you develo ...

Warning Letter Resolution

We will help you identify all the regulatory issues, help you resolve them, and draft a response to FDA to help you close out your Warning Let ...

Medical Device Label Review

Get an expert review for FDA labeling compliance.

$1199

Medical Device Quality System Regulations (GMPs)

Get expert consultation on your current QSR/GMPs or help building your new plans.

Medical Device Reporting

Let us submit your electronic reports.

Facility Inspection Assistance

We will help you during the inspection and help you draft answers to FDA's objections and observations. Get expert help responding to an FDA I ...

U.S. Agent Service

The FDA mandates that non-US food companies designate a US Agent for registration. As part ...

$99 per year

FDA Export Certificates

Get your export certificates. Call us if you need Apostilles.

$249

Recall Plan

Get a custom Recall Plan. Our FDA Recall Plan service provides you with a comprehensive se ...

$499

IHCTOA Letter Resolution

We will help you identify all the regulatory issues and help you resolve your IHCTOA ASAP by responding to FDA with an expertly written respon ...

Export FDA Unapproved Products

Our experts will guide and consult with you through the requirements for exporting products not approved in the US. We evaluate your products ...

Untitled Letters

We will help you identify all the regulatory issues, help you resolve your Untitled Letter, by responding to FDA to help you close out your Un ...

OTC Drug Label Review

Get an expert label review for FDA OTC compliance (monograph or homeopathic).

$1499

Modify VS Permit

Let us make changes to your existing VS permit. A VS Permit is required for animal product ...

$279

VS Permit (Renewal)

Let us renew your VS Permit. A VS Permit is required for animal products that could potent ...

$299

OTC Drug Claims Review

Get an expert review of all your claims for FDA and FTC compliance.

Homeopathic Drug Regulatory Review

Homeopathic drugs have specific, unique requirements based on loose FDA policy. This repor ...

$1499

Drug Regulatory Review

Homeopathic drugs have specific, unique requirements based on loose FDA policy. This repor ...

$1499

OTC Drug Formulation Review

To market your OTC drug you need to comply with the right monograph and a number of other ...

$1499

Serious Adverse Events Reporting Service

We can set up a dedicated phone line for OTC drugs, Cosmetics, or Dietary Supplement adverse events reporting. We can even receive the reports ...

Warning Letter Resolution

We will help you identify all the regulatory issues, help you resolve them, and draft a response to FDA to help you close out your Warning Let ...

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

FDA Import Hold / Detention Resolution

Get expert assistance today. Get help for your detained shipment today. If it is possible, we can help you get your shipment released. Let our ...

Import Alert Resolution

We will help you develop a corrective action plan and create a petition for removal from Import Alert Our team of experts will help you develo ...

Drug Good Manufacturing Practices (GMPs) Compliance

Get expert consultation on your current GMPs or help building your new GMP plans.

Facility Inspection Assistance

We will help you during the inspection and help you draft answers to FDA's objections and observations. Get expert help responding to an FDA I ...

U.S. Agent Service

The FDA mandates that non-US food companies designate a US Agent for registration. As part ...

$99 per year

Recall Plan

Get a custom Recall Plan. Our FDA Recall Plan service provides you with a comprehensive se ...

$499

Emergency Permit / On-Hold Shipment

Get an Emergency Permit (On-Hold Shipment) to resolve your EAN. Let us help you get an eme ...

$1999

FDA Export Certificates

Get your export certificates. Call us if you need Apostilles.

$249

VS Permit

Get your VS Permit here! A VS Permit is required for animal products that could potentiall ...

$599

Export FDA Unapproved Products

Our experts will guide and consult with you through the requirements for exporting products not approved in the US. We evaluate your products ...

Untitled Letters

We will help you identify all the regulatory issues, help you resolve your Untitled Letter, by responding to FDA to help you close out your Un ...

Food Facility Registration & U.S. Agent Service

Use our registration tool to easily register today! To enter the US market, every food man ...

$199

Food Facility Registration Renewal

Let us renew your facility registration. It's critical to renew the registration of your f ...

$99

Animal Food State Registration

We will register you company and your products with any state.

SID Filing
(LACF / Acidified)

Let us handle your Low Acid Food process filings. Scheduled processes are used by canning establishments in the manufacture and processing of ...

Modify PPQ Permit

Let us make changes to your existing PPQ Permit. A PPQ Permit is required for plant produc ...

$199

PPQ Permit (Renewal)

Let us renew your PPQ Permit. A PPQ Permit is required for plant products that could poten ...

$199

Modify VS Permit

Let us make changes to your existing VS permit. A VS Permit is required for animal product ...

$279

VS Permit (Renewal)

Let us renew your VS Permit. A VS Permit is required for animal products that could potent ...

$299

State Feed Tonnage Reporting

Let us file your tonnage

Animal Food Label Review

Get an expert review for FDA, state, and AAFCO labeling compliance Our comprehensive revie ...

$999

Animal Food Ingredient Review

Get an expert ingredient review to make sure your ingredients have the required AAFCO definition or are GRAS.

Animal Food Claims Review

Get an expert claims review to make sure your products comply with AAFCO defintiions and FTC rules.

Foreign Supplier Verification Program (FSVP) Plan

Build a Foreign Supplier Verification Plan (FSVP) with us today! FSVP stands for Foreign S ...

$1499

Food Defense Plan

Get a custom Food Defense Plan. Our service offers excellent documents and templates that guide you in creating your own FDA Food Defense Plan ...

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

Warning Letter Resolution

We will help you identify all the regulatory issues, help you resolve them, and draft a response to FDA to help you close out your Warning Let ...

FDA Import Hold / Detention Resolution

Get expert assistance today. Get help for your detained shipment today. If it is possible, we can help you get your shipment released. Let our ...

Import Alert Resolution

We will help you develop a corrective action plan and create a petition for removal from Import Alert Our team of experts will help you develo ...

VS Permit

Get your VS Permit here! A VS Permit is required for animal products that could potentiall ...

$599

PPQ Permit

Get your PPQ, CITES, or FAVIR permit here. A PPQ Permit is required for plant products tha ...

$599

Emergency Permit / On-Hold Shipment

Get an Emergency Permit (On-Hold Shipment) to resolve your EAN. Let us help you get an eme ...

$1999

Animal Food Regulatory Review

Get an evaluation of your product's FDA requirements. Our regulatory review will provide a ...

$349

Low Acid Canned Food / Acidified Food Establishment Registration

Let us submit your registration. If you produce low-acid foods, you need to register as a food canning establishment (FCE) with the FDA. This ...

Facility Inspection Assistance

We will help you during the inspection and help you draft answers to FDA's objections and observations. Get expert help responding to an FDA I ...

U.S. Agent Service

The FDA mandates that non-US food companies designate a US Agent for registration. As part ...

$99 per year

Food Safety Plan

Get a Food Safety Plan Review. Our team of food safety experts can evaluate your company's ...

$899

Recall Plan

Get a custom Recall Plan. Our FDA Recall Plan service provides you with a comprehensive se ...

$499

FDA Export Certificates

Get your export certificates. Call us if you need Apostilles.

$249

Export FDA Unapproved Products

Our experts will guide and consult with you through the requirements for exporting products not approved in the US. We evaluate your products ...

Untitled Letters

We will help you identify all the regulatory issues, help you resolve your Untitled Letter, by responding to FDA to help you close out your Un ...

Nutrition Facts

Get a custom built Nutrition Facts panel. Our nutrition facts panel creation service is a ...

$99

Food Facility Registration & U.S. Agent Service

Use our registration tool to easily register today! To enter the US market, every food man ...

$199

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

New Dietary Ingredient Notification

Let us help you prepare a dietary ingredient notification.

SID Filing
(LACF / Acidified)

Let us handle your Low Acid Food process filings. Scheduled processes are used by canning establishments in the manufacture and processing of ...

510(k) Filing

Get expert help drafting and submitting your 510k.

Animal Food Label Review

Get an expert review for FDA, state, and AAFCO labeling compliance Our comprehensive revie ...

$999

Cosmetic Ingredient Review

We will review your ingredients for safety to make sure you comply with MOCRA. Get your ingredients reviewed for safety to make sure you compl ...

Cosmetic Label Review

Get an expert review for FDA labeling compliance. Our review will tell you everything you ...

$749

Cosmetic Product Listing

Get your MOCRA Product Listings. Buy 5, Get 1 free.

$149

Dietary Supplement Ingredient Compliance

Get critical information about the safety and legal status of your dietary ingredients.

Dietary Supplement Label Review

Get an expert review for FDA labeling compliance.

$999

Dietary Supplement Regulatory Review

Get a supplement evaluation of your product's FDA compliance and an explanation of all you ...

$349

Cosmetic Facility Registration

Get your facility registered before MOCRA goes into effect.

$299

Dietary Supplement Facility Registration

Use our registration tool to register your facility.

$199

Medical Device Facility Registration

Get your facility registered.

$499

Medical Device Listing

Let us list your products.

$99 each

PPQ Permit

Get your PPQ, CITES, or FAVIR permit here. A PPQ Permit is required for plant products tha ...

$599

VS Permit

Get your VS Permit here! A VS Permit is required for animal products that could potentiall ...

$599

Food Ingredient Review

Get an expert ingredient review of all your food ingredients for FDA and FTC compliance.

Food Label Review

Get an expert review for FDA labeling compliance. Our comprehensive review is aimed at ass ...

$749

Food Regulatory Review

Get an evaluation of your product's FDA requirements. Our regulatory review will provide a ...

$349

Animal Food Regulatory Review

Get an evaluation of your product's FDA requirements. Our regulatory review will provide a ...

$349

Homeopathic Drug Regulatory Review

Homeopathic drugs have specific, unique requirements based on loose FDA policy. This repor ...

$1499

Drug Regulatory Review

Homeopathic drugs have specific, unique requirements based on loose FDA policy. This repor ...

$1499

OTC Drug Label Review

Get an expert label review for FDA OTC compliance (monograph or homeopathic).

$1499

Low Acid Canned Food / Acidified Food Establishment Registration

Let us submit your registration. If you produce low-acid foods, you need to register as a food canning establishment (FCE) with the FDA. This ...

Medical Device Label Review

Get an expert review for FDA labeling compliance.

$1199

Medical Device Regulatory Review

We will classify your device and explain all your obligations.

$1499

OTC Drug Formulation Review

To market your OTC drug you need to comply with the right monograph and a number of other ...

$1499

Supplement Facts Label

Get a custom-built Supplement Facts panel.

$299

Animal Food State Registration

We will register you company and your products with any state.

Food Claims Review

Get an expert review of all your claims for FDA and FTC compliance. Claims are a key target for FDA and FTC enforcement. Our evaluation can as ...

Cosmetic Label Review

Get an expert review for FDA labeling compliance. Our review will tell you everything you ...

$749

Food Label Review

Get an expert review for FDA labeling compliance. Our comprehensive review is aimed at ass ...

$749

Nutrition Facts

Get a custom built Nutrition Facts panel. Our nutrition facts panel creation service is a ...

$99

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

Animal Food Claims Review

Get an expert claims review to make sure your products comply with AAFCO defintiions and FTC rules.

Animal Food Label Review

Get an expert review for FDA, state, and AAFCO labeling compliance Our comprehensive revie ...

$999

OTC Drug Claims Review

Get an expert review of all your claims for FDA and FTC compliance.

Cosmetic Claims Review

Get an expert review of your claims today!

Courtesy Letter Help

Let us help you understand the effect of FDA’s Courtesy Letter. We will review your claims, change them if needed, and prepare to file a suc ...

Dietary Supplement Claims Review

Get an expert review of all your claims for FDA and FTC compliance.

Dietary Supplement Label Review

Get an expert review for FDA labeling compliance.

$999

OTC Drug Label Review

Get an expert label review for FDA OTC compliance (monograph or homeopathic).

$1499

Medical Device Label Review

Get an expert review for FDA labeling compliance.

$1199

Structure / Function Notification

We will draft and submit your letter for an affordable flat-fee. We will help you avoid pu ...

$199

Supplement Facts Label

Get a custom-built Supplement Facts panel.

$299

SID Filing
(LACF / Acidified)

Let us handle your Low Acid Food process filings. Scheduled processes are used by canning establishments in the manufacture and processing of ...

U.S. Agent Service

The FDA mandates that non-US food companies designate a US Agent for registration. As part ...

$99 per year

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

Low Acid Canned Food / Acidified Food Establishment Registration

Let us submit your registration. If you produce low-acid foods, you need to register as a food canning establishment (FCE) with the FDA. This ...

Food Facility Registration & U.S. Agent Service

Use our registration tool to easily register today! To enter the US market, every food man ...

$199

California Safe Cosmetics Filing

We will file your products with California. Buy 5, Get 1 free

$499

Cosmetic Product Listing

Get your MOCRA Product Listings. Buy 5, Get 1 free.

$149

Medical Device Facility Registration

Get your facility registered.

$499

Medical Device Listing

Let us list your products.

$99 each

Cosmetic Facility Registration

Get your facility registered before MOCRA goes into effect.

$299

Dietary Supplement Facility Registration

Use our registration tool to register your facility.

$199

Food Facility Registration Renewal

Let us renew your facility registration. It's critical to renew the registration of your f ...

$99

Dietary Supplement Facility Registration Renewal

Let us renew your facility registration. It's critical to renew the registration of your f ...

$99

State Feed Tonnage Reporting

Let us file your tonnage

Animal Food State Registration

We will register you company and your products with any state.

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

Warning Letter Resolution

We will help you identify all the regulatory issues, help you resolve them, and draft a response to FDA to help you close out your Warning Let ...

IHCTOA Letter Resolution

We will help you identify all the regulatory issues and help you resolve your IHCTOA ASAP by responding to FDA with an expertly written respon ...

Untitled Letters

We will help you identify all the regulatory issues, help you resolve your Untitled Letter, by responding to FDA to help you close out your Un ...

Facility Inspection Assistance

We will help you during the inspection and help you draft answers to FDA's objections and observations. Get expert help responding to an FDA I ...

Medical Device Quality System Regulations (GMPs)

Get expert consultation on your current QSR/GMPs or help building your new plans.

Foreign Supplier Verification Program (FSVP) Plan

Build a Foreign Supplier Verification Plan (FSVP) with us today! FSVP stands for Foreign S ...

$1499

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

Food Safety Plan

Get a Food Safety Plan Review. Our team of food safety experts can evaluate your company's ...

$899

Recall Plan

Get a custom Recall Plan. Our FDA Recall Plan service provides you with a comprehensive se ...

$499

Food Defense Plan

Get a custom Food Defense Plan. Our service offers excellent documents and templates that guide you in creating your own FDA Food Defense Plan ...

Serious Adverse Events Reporting Service

We can set up a dedicated phone line for OTC drugs, Cosmetics, or Dietary Supplement adverse events reporting. We can even receive the reports ...

Drug Good Manufacturing Practices (GMPs) Compliance

Get expert consultation on your current GMPs or help building your new GMP plans.

FSVP for Dietary Supplements

Build a Foreign Supplier Verification Plan (FSVP) with us today!

$1499

Dietary Supplement Good Manufacturing Practices (GMPs) Compliance

Get expert consultation on your current GMPs or help building your new GMP plans.

California Safe Cosmetics Filing

We will file your products with California. Buy 5, Get 1 free

$499

Cosmetic Ingredient Review

We will review your ingredients for safety to make sure you comply with MOCRA. Get your ingredients reviewed for safety to make sure you compl ...

Cosmetic Product Listing

Get your MOCRA Product Listings. Buy 5, Get 1 free.

$149

Cosmetics Good Manufacturing Practices (GMPs) Compliance

Get expert consultation on your current GMPs or help building your new GMP plans ahead of the MOCRA compliance date. Work with experts develop ...

Medical Device Reporting

Let us submit your electronic reports.

510(k) Filing

Get expert help drafting and submitting your 510k.

Structure / Function Notification

We will draft and submit your letter for an affordable flat-fee. We will help you avoid pu ...

$199

Medical Device Regulatory Review

We will classify your device and explain all your obligations.

$1499

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

New Dietary Ingredient Notification

Let us help you prepare a dietary ingredient notification.

Animal Food Ingredient Review

Get an expert ingredient review to make sure your ingredients have the required AAFCO definition or are GRAS.

Dietary Supplement Ingredient Compliance

Get critical information about the safety and legal status of your dietary ingredients.

Dietary Supplement Regulatory Review

Get a supplement evaluation of your product's FDA compliance and an explanation of all you ...

$349

Food Ingredient Review

Get an expert ingredient review of all your food ingredients for FDA and FTC compliance.

Food Regulatory Review

Get an evaluation of your product's FDA requirements. Our regulatory review will provide a ...

$349

Animal Food Regulatory Review

Get an evaluation of your product's FDA requirements. Our regulatory review will provide a ...

$349

Homeopathic Drug Regulatory Review

Homeopathic drugs have specific, unique requirements based on loose FDA policy. This repor ...

$1499

Drug Regulatory Review

Homeopathic drugs have specific, unique requirements based on loose FDA policy. This repor ...

$1499

OTC Drug Formulation Review

To market your OTC drug you need to comply with the right monograph and a number of other ...

$1499

Modify VS Permit

Let us make changes to your existing VS permit. A VS Permit is required for animal product ...

$279

VS Permit (Renewal)

Let us renew your VS Permit. A VS Permit is required for animal products that could potent ...

$299

Modify PPQ Permit

Let us make changes to your existing PPQ Permit. A PPQ Permit is required for plant produc ...

$199

PPQ Permit (Renewal)

Let us renew your PPQ Permit. A PPQ Permit is required for plant products that could poten ...

$199

VS Permit

Get your VS Permit here! A VS Permit is required for animal products that could potentiall ...

$599

PPQ Permit

Get your PPQ, CITES, or FAVIR permit here. A PPQ Permit is required for plant products tha ...

$599

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

FDA Export Certificates

Get your export certificates. Call us if you need Apostilles.

$249

Foreign Supplier Verification Program (FSVP) Plan

Build a Foreign Supplier Verification Plan (FSVP) with us today! FSVP stands for Foreign S ...

$1499

Emergency Permit / On-Hold Shipment

Get an Emergency Permit (On-Hold Shipment) to resolve your EAN. Let us help you get an eme ...

$1999

Import Alert Resolution

We will help you develop a corrective action plan and create a petition for removal from Import Alert Our team of experts will help you develo ...

FSVP for Dietary Supplements

Build a Foreign Supplier Verification Plan (FSVP) with us today!

$1499

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

FDA Import Hold / Detention Resolution

Get expert assistance today. Get help for your detained shipment today. If it is possible, we can help you get your shipment released. Let our ...

Emergency Permit / On-Hold Shipment

Get an Emergency Permit (On-Hold Shipment) to resolve your EAN. Let us help you get an eme ...

$1999

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

Warning Letter Resolution

We will help you identify all the regulatory issues, help you resolve them, and draft a response to FDA to help you close out your Warning Let ...

FDA Import Hold / Detention Resolution

Get expert assistance today. Get help for your detained shipment today. If it is possible, we can help you get your shipment released. Let our ...

Facility Inspection Assistance

We will help you during the inspection and help you draft answers to FDA's objections and observations. Get expert help responding to an FDA I ...

IHCTOA Letter Resolution

We will help you identify all the regulatory issues and help you resolve your IHCTOA ASAP by responding to FDA with an expertly written respon ...

Untitled Letters

We will help you identify all the regulatory issues, help you resolve your Untitled Letter, by responding to FDA to help you close out your Un ...

FDA Import Hold / Detention Resolution

Get expert assistance today. Get help for your detained shipment today. If it is possible, we can help you get your shipment released. Let our ...

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

Emergency Permit / On-Hold Shipment

Get an Emergency Permit (On-Hold Shipment) to resolve your EAN. Let us help you get an eme ...

$1999

Import Alert Resolution

We will help you develop a corrective action plan and create a petition for removal from Import Alert Our team of experts will help you develo ...

General Consultation

Get expert assistance today. Get professional assistance with any regulatory issue. Our te ...

$375 per hour

FDA Export Certificates

Get your export certificates. Call us if you need Apostilles.

$249

Export FDA Unapproved Products

Our experts will guide and consult with you through the requirements for exporting products not approved in the US. We evaluate your products ...

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U.S. Regulations Require All Food Facilities (E.G., That Manufacture, Process, Pack, Or Hold Food, Beverages, Or Dietary Supplements For And Food Facilities Located Outside The United States Must Designate A U.S. Agent.

$499 Per Facility
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