North American Site Licensing Services
North American Site Licensing Services
North American Site Licensing Services
Comprehensive Health Canada and USFDA Licensing & Compliance
At DropSupplements, we simplify regulatory compliance for supplement companies entering the Canadian and U.S. markets.
From Health Canada NHP Site Licenses to USFDA registrations, we manage every detail to ensure your facility meets all requirements for smooth market access.
Here’s how we support your success:
- Canada NHP Site Licenses
We handle licensing, including preparing Quality Assurance Reports (QARs) to demonstrate cGMP compliance.
- USFDA Facility Registrations
We manage FDA registration, act as your U.S. Agent, and provide FSVP representation for full U.S. compliance.
- GMP-Compliant Systems & Audits
We establish compliant systems and conduct audits to prepare your facility for inspections.
- License Renewals and Amendments
We manage updates and renewals to keep your compliance current.
Comprehensive Health Canada and USFDALicensing & Compliance
At DropSupplements, we simplify regulatory compliance for supplement companies entering the Canadian and U.S. markets. From Health Canada NHP Site Licenses to USFDA registrations, we manage every detail to ensure your facility meets all requirements for smooth market access.
Here’s how we support your success:
- Canada NHP Site Licenses
We handle licensing, including preparing Quality Assurance Reports (QARs) to demonstrate cGMP compliance.
- USFDA Facility Registrations
We manage FDA registration, act as your U.S. Agent, and provide FSVP representation for full
U.S. compliance.
- GMP-Compliant Systems & Audits
We establish compliant systems and conduct audits to prepare your facility for
inspections.
- License Renewals and Amendments
We manage updates and renewals to keep your compliance current.
Comprehensive Health
Canada and USFDA
Licensing & Compliance
At DropSupplements, we simplify regulatory compliance for supplement companies entering the Canadian and U.S. markets. From Health Canada NHP Site Licenses to USFDA registrations, we manage every detail to ensure your facility meets all requirements for smooth market access.
Here’s how we support your success:
- Canada NHP Site Licenses
We handle licensing, including preparing Quality Assurance Reports (QARs) to demonstrate cGMP compliance.
- USFDA Facility Registrations
We manage FDA registration, act as your U.S. Agent, and provide FSVP representation for full U.S. compliance.
- GMP-Compliant Systems & Audits
We establish compliant systems and conduct audits to prepare your facility for inspections.
- License Renewals and Amendments
We manage updates and renewals to keep your compliance current.
Canadian Site Licensing – Health Canada NHP Site License
Simplify Your Compliance Journey with DropSupplements
If you are a manufacturer, packager, labeler, or exporter looking to register your facility with Health Canada, DropSupplements is your trusted partner. We streamline the process, ensuring your compliance journey is smooth and efficient.
Expert Support for Key Activities
Our services cover critical aspects of compliance, including manufacturing, packaging, labeling, and exporting, ensuring every step meets Health Canada’s rigorous standards.
Manufacturing
Packaging
Labeling
Importing
Comprehensive Licensing Services
We handle the entire process for you. This includes preparing GMP documentation, ensuring employee training records are aligned with compliance requirements, and streamlining technical processes to meet Health Canada’s expectations.
Canadian Site Licensing – Health Canada NHP Site License
Simplify Your Compliance Journey with DropSupplements
If you are a manufacturer, packager, labeler, or exporter looking to register your facility with Health Canada, DropSupplements is your trusted partner. We streamline the process, ensuring your compliance journey is smooth and efficient.
Expert Support for Key Activities
Our services cover critical aspects of compliance, including manufacturing, packaging, labeling, and exporting, ensuring every step meets Health Canada’s rigorous standards.
Manufacturing
Packaging
Labeling
Importing
Comprehensive Licensing Services
We handle the entire process for you. This includes preparing GMP documentation, ensuring employee training records are aligned with compliance requirements, and streamlining technical processes to meet Health Canada’s expectations.
Canadian Site Licensing – Health Canada NHP Site License
Simplify Your Compliance Journey with DropSupplements
Simplify Your Compliance Journey with DropSupplements.
Expert Support for Key Activities
Our services cover critical aspects of compliance, including manufacturing, packaging, labeling, and exporting, ensuring every step meets Health Canada’s rigorous standards.
Manufacturing
Packaging
Labeling
Importing
Comprehensive Licensing Services
We handle the entire process for you. This includes preparing GMP documentation, ensuring employee training records are aligned with compliance requirements, and streamlining technical processes to meet Health Canada’s expectations.
U.S. Site Licensing – FDA Facility Registration and Compliance Your Gateway to the U.S. Market
U.S. Site Licensing – FDA Facility Registration and Compliance Your Gateway to the U.S. Market
In the U.S., FDA registration is mandatory for facilities manufacturing, processing, packaging, or holding dietary supplements. We guide you through the entire registration process, including biennial renewals, to ensure seamless compliance.
DUNS Number Registration
We assist in obtaining your DUNS number, a unique identifier required by the FDA for facility registration and FSVP compliance.
U.S. Agent Services
As your U.S. Agent, we serve as the point of contact for FDA communications, ensuring your facility is prepared for regulatory inquiries and emergencies.
In the U.S., FDA registration is mandatory for facilities manufacturing, processing, packaging, or holding dietary supplements. We guide you through the entire registration process, including biennial renewals, to ensure seamless compliance.
DUNS Number Registration
We assist in obtaining your DUNS number, a unique identifier required by the FDA for facility registration and FSVP compliance.
U.S. Agent Services
As your U.S. Agent, we serve as the point of contact for FDA communications,
ensuring your facility is prepared for
regulatory
inquiries and emergencies.
U.S. Site Licensing – FDA Facility Registration and Compliance Your Gateway to the U.S. Market
In the U.S., FDA registration is mandatory for facilities manufacturing, processing, packaging, or holding dietary supplements. We guide you through the entire registration process, including biennial renewals, to ensure seamless compliance.
DUNS Number Registration
We assist in obtaining your DUNS number, a unique identifier required by the FDA for facility registration and FSVP compliance.
U.S. Agent Services
As your U.S. Agent, we serve as the point of contact for FDA communications, ensuring your facility is prepared for regulatory
inquiries and emergencies.
Foreign Supplier Verification
Program (FSVP)
Under the FDA Food Safety Modernization Act (FSMA), the Foreign Supplier Verification Program (FSVP)
mandates that importers verify foreign suppliers’ adherence to FDA food safety standards.
Foreign Supplier Verification Program (FSVP)
Under the FDA Food Safety Modernization Act (FSMA), the Foreign Supplier Verification Program (FSVP) mandates that importers verify foreign suppliers’ adherence to FDA food safety standards.
Foreign Supplier Verification
Program (FSVP)
Under the FDA Food Safety Modernization Act (FSMA), the Foreign Supplier Verification Program (FSVP)
mandates that importers verify foreign suppliers’ adherence to FDA food safety standards.
As your FSVP agent, we provide:
- Hazard Analysis
Identification and assessment of potential food safety risks.
- Supplier Verification
Conducting audits and evaluating safety measures.
- Record Maintenance
Storing verification records for FDA review.
- FSVP Plan Development
Crafting a tailored FSVP plan that aligns with FDA regulations.
Our FSVP services ensure your imported products meet the FDA’s stringent safety standards, safeguarding your business’s market access and reputation
As your FSVP agent, we provide:
- Hazard Analysis
Identification and assessment of potential food safety risks.
- Supplier Verification
Conducting audits and evaluating safety measures.
- Record Maintenance
Storing verification records for FDA review.
- FSVP Plan Development
Crafting a tailored FSVP plan that aligns with FDA regulations.
Our FSVP services ensure your imported products meet the FDA’s stringent safety standards, safeguarding your business’s market access and reputation
As your FSVP agent, we provide:
- Hazard Analysis
Identification and assessment of potential food safety risks.
- Supplier Verification
Conducting audits and evaluating safety measures.
- Record Maintenance
Storing verification records for FDA review.
- FSVP Plan Development
Crafting a tailored FSVP plan that aligns with FDA regulations.
Our FSVP services ensure your imported products meet the FDA’s stringent safety standards, safeguarding your business’s market access and reputation
Dropsupplements Guarantee
We guarantee your Health Canada cGMP Site License and USFDA Facility Registration Approval, handling the entire regulatory process for seamless North American Market Entry.
Dropsupplements Guarantee
We guarantee your Health Canada cGMP Site License and USFDA Facility Registration Approval, handling the entire regulatory process for seamless North American Market Entry.
DropSupplements Guarantee
We guarantee your Health Canada cGMP Site License and USFDA Facility Registration Approval, handling the entire regulatory process for seamless North American Market Entry.
Our FAQs provide answers to common questions about North American site licensing. For additional inquiries or to discuss your licensing needs, contact us today.
Popular Questions
Got a question? We’re here to help.
-
When I partner with Dropsupplements, is everything covered?
Yes, all licensing services for both Canadian and U.S. markets—including NPN applications, FDA compliance, U.S. Agent and FSVP Importer services, QAP services, and ongoing regulatory support—are included.
-
What is a Health Canada NHP Site License?
An NHP Site License is a Health Canada authorization for manufacturing, labeling, packaging, or importing natural health products in Canada, ensuring compliance with Good Manufacturing Practices (GMPs).
-
Why is FDA facility registration required in the U.S.?
FDA registration is necessary for any facility producing or holding dietary supplements in the U.S., allowing the FDA to monitor compliance and uphold product safety standards
-
What is the role of a U.S. Agent?
A U.S. Agent acts as a domestic representative for foreign facilities, handling FDA communication and compliance. This role is essential for FDA registration and responding to regulatory inquiries or emergencies.
-
What is the Foreign Supplier Verification Program (FSVP)?
FSVP is a regulatory program under FSMA, requiring importers to verify foreign suppliers’ compliance with FDA safety standards, ensuring imported foods meet U.S. standards.
-
Do I need both a U.S. Agent and an FSVP Agent?
Yes, the U.S. Agent manages FDA communication for the facility, while the FSVP Agent verifies imported food products’ compliance with safety standards.
-
What does the application process involve?
Applying for a Health Canada NHP Site License or FDA facility registration requires submitting detailed compliance documents, including GMP records, employee training, and technical documentation. Health Canada may conduct a pre-inspection review, while the FDA requires a biennial renewal.
-
How do I manage amendments to my license?
Amendments may be required if regulatory guidelines change or operations expand. We assist in making these updates, ensuring full compliance with Health Canada or FDA requirements.
-
Do I need a DUNS Number?
Yes, FDA requires a DUNS Number for identifying FSVP Importers. It’s part of the compliance requirements for importers managing FDA entries.
Our FAQs provide answers to common questions about North American site licensing. For additional inquiries or to discuss your licensing needs, contact us today.
Popular Questions
Got a question? We’re here to help.
-
When I partner with Dropsupplements, is everything covered?
Yes, all licensing services for both Canadian and U.S. markets—including NPN applications, FDA compliance, U.S. Agent and FSVP Importer services, QAP services, and ongoing regulatory support—are included.
-
What is a Health Canada NHP Site License?
An NHP Site License is a Health Canada authorization for manufacturing, labeling, packaging, or importing natural health products in Canada, ensuring compliance with Good Manufacturing Practices (GMPs).
-
Why is FDA facility registration required in the U.S.?
FDA registration is necessary for any facility producing or holding dietary supplements in the U.S., allowing the FDA to monitor compliance and uphold product safety standards
-
What is the role of a U.S. Agent?
A U.S. Agent acts as a domestic representative for foreign facilities, handling FDA communication and compliance. This role is essential for FDA registration and responding to regulatory inquiries or emergencies.
-
What is the Foreign Supplier Verification Program (FSVP)?
FSVP is a regulatory program under FSMA, requiring importers to verify foreign suppliers’ compliance with FDA safety standards, ensuring imported foods meet U.S. standards.
-
Do I need both a U.S. Agent and an FSVP Agent?
Yes, the U.S. Agent manages FDA communication for the facility, while the FSVP Agent verifies imported food products’ compliance with safety standards.
-
What does the application process involve?
Applying for a Health Canada NHP Site License or FDA facility registration requires submitting detailed compliance documents, including GMP records, employee training, and technical documentation. Health Canada may conduct a pre-inspection review, while the FDA requires a biennial renewal.
-
How do I manage amendments to my license?
Amendments may be required if regulatory guidelines change or operations expand. We assist in making these updates, ensuring full compliance with Health Canada or FDA requirements.
-
Do I need a DUNS Number?
Yes, FDA requires a DUNS Number for identifying FSVP Importers. It’s part of the compliance requirements for importers managing FDA entries.
Our FAQs provide answers to common questions about North American site licensing. For additional inquiries or to discuss your licensing needs, contact us today.
Popular Questions
Got a question? We’re here to help.
-
When I partner with Dropsupplements, is everything covered?
Yes, all licensing services for both Canadian and U.S. markets—including NPN applications, FDA compliance, U.S. Agent and FSVP Importer services, QAP services, and ongoing regulatory support—are included.
-
What is a Health Canada NHP Site License?
An NHP Site License is a Health Canada authorization for manufacturing, labeling, packaging, or importing natural health products in Canada, ensuring compliance with Good Manufacturing Practices (GMPs).
-
Why is FDA facility registration required in the U.S.?
FDA registration is necessary for any facility producing or holding dietary supplements in the U.S., allowing the FDA to monitor compliance and uphold product safety standards
-
What is the role of a U.S. Agent?
A U.S. Agent acts as a domestic representative for foreign facilities, handling FDA communication and compliance. This role is essential for FDA registration and responding to regulatory inquiries or emergencies.
-
What is the Foreign Supplier Verification Program (FSVP)?
FSVP is a regulatory program under FSMA, requiring importers to verify foreign suppliers’ compliance with FDA safety standards, ensuring imported foods meet U.S. standards.
-
Do I need both a U.S. Agent and an FSVP Agent?
Yes, the U.S. Agent manages FDA communication for the facility, while the FSVP Agent verifies imported food products’ compliance with safety standards.
-
What does the application process involve?
Applying for a Health Canada NHP Site License or FDA facility registration requires submitting detailed compliance documents, including GMP records, employee training, and technical documentation. Health Canada may conduct a pre-inspection review, while the FDA requires a biennial renewal.
-
How do I manage amendments to my license?
Amendments may be required if regulatory guidelines change or operations expand. We assist in making these updates, ensuring full compliance with Health Canada or FDA requirements.
-
Do I need a DUNS Number?
Yes, FDA requires a DUNS Number for identifying FSVP Importers. It’s part of the compliance requirements for importers managing FDA entries.