Terms of Service
Effective Date: January 1, 2025
Operated by: FSVPServices.com, a service platform of Consultare Inc. Group, A Compliance Company (“Company”)
Please read these Terms of Service ("Terms") carefully before using the services provided by FSVPServices.com. By accessing or using our website, services, or engaging with us as a client, you (the “Client”) agree to be bound by these Terms.
1. Scope of Services
FSVPServices.com provides compliance and regulatory support services, including but not limited to:
• Foreign Supplier Verification Program (FSVP) Agent and Qualified Individual (FSVPQI) services
• U.S. FDA U.S. Agent representation
• Importer of Record (IOR) representation and administrative facilitation
• FDA registration assistance
• Compliance documentation management
• Regulatory training and consulting
• Preventive Controls Qualified Individual (PCQI) support
• Regulatory review of product labeling and documentation
• Facilitation of submissions to FDA, USDA, or other U.S. regulatory agencies
All services are rendered under the management and direction of Consultare Inc. Group, A Compliance Company.
2. Eligibility
By engaging the Company’s services, the client affirms that they:
• Are at least 18 years old or of legal age to enter into a binding agreement
• Are authorized to act on behalf of the business entity they represent
3. Client Responsibilities
The Client agrees to:
• Provide accurate, timely, and complete business, supplier, and product information.
• Cooperate in providing required documentation, records, and declarations necessary for compliance with regulatory authorities (e.g., FDA, USDA, CBP, FTC).
• Inform FSVPServices.com of any regulatory updates, inspections, or enforcement actions related to their company or products.
• Maintain active and timely communication with FSVPServices.com to facilitate due diligence in the execution of services.
• Acknowledge that ultimate compliance responsibility lies with the Client and/or their suppliers unless otherwise stated.
4. Fees and Payment
4.1 Pricing for Services
All payments are:
• Due in full prior to service activation unless otherwise agreed;
• Non-refundable under any circumstances;
• Subject to a late fee of twenty percent (20%) of the total outstanding balance to cover reprocessing and accounting expenses, in addition to potential suspension of services for non-payment; and
• Evaluated at the Company’s sole discretion for reinstatement of service once full payment, including late fees, has been received.
4.2 Subscription and Project Terms
• One-Time (Project-Based) engagements are invoiced as a single payment and prepaid.
• Long-Term (Subscription) services are billed monthly and prepaid.
• Installments: Clients opting for monthly installment payments may incur an interest rate of not less than seven percent (7%) of the total project cost. Installment payments must follow the agreed schedule to maintain engagement validity.
4.3 Rollover Policy
For clients under monthly retainers, unused service hours or credits may roll over for up to three (3) months. After this period, any unused balance is forfeited.
4.4 Non-Payment
In the event of non-payment, all service engagements will immediately cease.
5. Service-Specific Terms
5.1 U.S. Agent and FSVP Agent Representation
• The Company’s designation as U.S. Agent or FSVP Agent is representational and does not transfer responsibility for product quality, labeling, or manufacturing.
• The Client remains responsible for corrective actions, documentation, verification activities, and compliance.
5.2 Importer of Record (IOR)
• The Company acts as IOR solely for regulatory filing purposes and not as the legal importer or owner of goods.
• The Client remains responsible for all costs, duties, and liabilities.
• The Company shall not be liable for delays, detentions, recalls, or enforcement actions caused by incomplete or inaccurate documentation.
5.3 FSVP Qualified Individual (FSVPQI) Services
• If designated as FSVPQI, the Company may provide oversight and review of supplier verification activities, and/or develop and implement the verifications thereof, per FDA requirements.
• This role does not absolve the Client of responsibilities to provide accurate supplier information and records and maintain compliance.
• By designating FSVPServices.com to appoint a Qualified Individual (QI) to support FSVP compliance, the Client agrees to provide accurate records or disclosures which the Company will utilize in its execution of the service scope with due diligence.
5.4 Preventive Controls Qualified Individual (PCQI) Services
• Services may include training, plan development, or verification support.
• Implementation of developed procedures remains the Client’s responsibility.
5.5 Regulatory Reviews
• Reviews are based on documentation submitted by the Client.
• Records must be provided within 10 business days of request unless otherwise stated.
• Reviews inactive for over 10 business days may be deemed closed and subject to reopening fees.
• Recommendations are advisory and do not guarantee regulatory acceptance.
5.6 Regulatory Submissions
• The Company facilitates submissions (e.g., FDA Prior Notice, USDA Permits, CBP filings) in an administrative capacity only.
• Accuracy depends on Client-provided data; regulatory outcomes cannot be guaranteed.
• Records must be provided within 10 business days of request unless otherwise stated.
• Pending information requests inactive for over 10 business days may be deemed closed and subject to reopening fees.
• [For renewal services] The Client may subscribe to the Company’s annual Regulatory Renewal Service covering permits, licenses, or authorizations required for importation, distribution, or compliance with applicable U.S. regulatory agencies. The subscription shall have a minimum commitment period stated herein, equivalent to the validity term of the applicable permit or license, as prescribed by the issuing authority. The Company shall facilitate renewal of the relevant authorization only upon confirmation that all subscription payments for the minimum commitment period have been fully settled, or otherwise meet the standard fee for a full renewal cycle, whichever is greater. In the event of incomplete payment, the Company shall have no obligation to initiate or proceed with any renewal process until all outstanding subscription fees have been paid in full.
– FSVP Agent/US Agent Representation – minimum of 12 months
– FDA Registration – minimum of 2 years
– USDA Permitting – minimum of 3 years
– Other services – subject to evaluation per regulatory requirements or as agreed upon in the contract
• For any regulatory filing, all government-imposed filing, permitting, submission, or renewal fees shall be borne solely by the Client and must be confirmed with the Company or remitted directly to the regulatory agency upon facilitation.
• If the Company determines that the facility, product, or commodity is inadmissible, ineligible, not subject to permitting, or otherwise does not require approval for importation, clearance, or entry, the Company shall issue an assessment report documenting the inadmissibility. No submission or permit filing shall be performed in such cases, and fees for services performed remain non-refundable.
5.7 Software Subscription
• The server storage fee is incorporated into the software subscription.
• If availed without an End-to-End Service, CIG reserves the right to decline any document for uploading. However, if an End-to-End Service is active, CIG will continue uploading the files within the client’s designated service hours.
• User account credentials will be maintained as confidential. The Client is responsible for all activity that occurs under its authorized accounts and acknowledges that the Company shall not be responsible for damages resulting from unauthorized access attributable to the Client’s internal misuse of credentials.
• Each Party shall be responsible for the actions of its respective Authorized Users. The Client shall ensure that only its designated personnel are provided with access under its subscription, and the Company shall ensure that its personnel accessing the System on behalf of the Client do so solely for the purpose of fulfilling the Company’s obligations under this Agreement.
• All modules, features, and functions specified in this Agreement are standard components of the subscribed package. Any additional feature(s) or modification beyond these inclusions are subject to review by InterlinkIQ and may be billed separately.
• All system upgrades and updates will be scheduled within 5 to 7 days prior, preferably during major holidays or when the facility is not in operation to minimize disruptions. Clients will be notified 5 to 7 days in advance of any scheduled maintenance to ensure minimal impact on operations.
• By subscribing to the software services indicated herein, the Client acknowledges that the Company will exercise all efforts, with due diligence, to maintain seamless access and operations for clients at 99% system uptime, 24 hours a day, 7 days a week, 365 days a year, except during scheduled maintenance, which typically lasts no longer than one (1) hour per day on average. Such downtimes or temporary interruptions are part of normal system maintenance and shall not constitute a failure of service.
• Each subscribed facility is entitled to a total storage capacity of up to 5 gigabytes (GB). This capacity covers all files, records, and documents uploaded or stored within the interlinkIQ Compliance Management System.
• Server storage assessment: Five dollars ($5.00) per gigabyte will be assessed annually on the anniversary of the subscription. Should the Client exceed the allotted capacity, users will be notified when usage surpasses the limit.
• A subsequent agreement between the Company and the Client is required prior to additional uploads, and additional storage may be availed as determined.
• Failure to pay the additional storage charges may result in suspension or termination of upload services until balances are settled.
• In the event of interruption in access to the InterlinkIQ Connectivity System due to non-payment, access may be reinstated upon full settlement of outstanding dues.
5.8 On-site Services
• On-site support (e.g., internal audit, consultancy, on-site audit support) may entail additional costs for miscellaneous fees (e.g., on-site consultancy, lodging, travel, meals) which are coordinated in advance and billed separately.
5.9 Oversight/Compliance Support Subscriptions
• In the event that the Client elects to cancel the subscription prior to the next billing period, the cancellation shall be subject to a cancellation fee equivalent to forty percent (40%) of the service rate applicable to the upcoming billing period.
• The Company reserves the right to withhold or deduct such amount from any remaining balance or to issue an invoice for the corresponding fee, payable upon receipt.
6. Confidentiality
For compliance projects:
• Clients must submit requested documentation or respond within 10 business days of request.
• Submissions within 30 days past the initial request may require a reopening fee of 40% of the project cost once the 10-day response window has elapsed.
• Lack of response after 30 days from the date of initial request constitutes project closure. Should the Client request to continue the project, this may be subject to a new engagement.
For deliverables:
• Clients must acknowledge acceptance or feedback within 20 calendar days of report issuance.
• No response within this timeframe constitutes project completion and closure.
7. Termination of Services
• Either party may terminate the agreement with 30 days’ written notice.
• [For project-based services] Once a client decides to terminate any service thereof, a termination fee of a minimum forty percent (40%) of the remaining balance, where applicable, may apply.
• Client documents within the InterlinkIQ system will be archived for 30 days after termination, after which they will be permanently deleted unless retrieval is requested.
• All payments, subscriptions, and service fees are non-refundable.
8. Confidentiality
The Company maintains strict confidentiality of all proprietary and sensitive information, except:
• As required by law, regulatory inquiry, or audit.
• With Client consent.
• Within authorized Consultare Inc. Group personnel for service facilitation.
9. Intellectual Property
All templates, materials, and content remain the intellectual property of Consultare Inc. Group and may not be copied, shared, or resold without written authorization.
10. Limitation of Liability
The Company shall not be liable for:
• Client products, records, or data loss.
• Regulatory enforcement due to incomplete or false client submissions, or inadmissibility per relevant guidelines.
• Third-party actions (e.g., freight forwarders, customs brokers, carriers).
• Any indirect, incidental, or consequential damages, including loss of revenue or profit.
11. Indemnification
The Client agrees to indemnify and hold harmless Consultare Inc. Group and its affiliates against any claims, costs, damages, or liabilities arising from:
• Client product non-compliance;
• False or incomplete documentation;
• Third-party errors or omissions; or
• Client’s regulatory infractions.
12. Disclaimer
• The Company is not a law firm and does not provide legal advice.
• Services are rendered on a best-effort basis under current regulations.
• The Company does not guarantee approvals, certifications, admissibility, or regulatory clearances.
• Engagement as FSVP Agent, U.S. Agent, IOR, PCQI, or FSVPQI does not transfer ownership or compliance responsibility.
13. Amendments
The Company reserves the right to amend these Terms at any time. Updates will be posted on FSVPServices.com and will automatically apply to all active and future contracts. Continued engagement or payment constitutes acceptance of revised Terms.
14. Governing Law
These Terms are governed by the laws of the State of Texas, United States, without regard to conflict of laws principles.
15. Contact Information
For questions, concerns, or legal correspondence regarding these Terms:
- Email: info@consultareinc.com
- Website: www.FSVPServices.com
