General Terms of Service
General conditions that apply to Access FDA regulatory services: scope, obligations, payments, term, limits and communications.
Draft pending legal review. This text is not yet the final, binding version.
Parties and scope
These General Terms govern the relationship between Grupo Nativot S.C., operating as Access FDA (“Access FDA”), and the individual or company that hires its services (“the Client”). The specific terms of each service (FDA Establishment Registration and U.S. Agent, Prior Notice, GMP Program, Consultations, among others) and the accepted proposal or scope of work complement these terms; in case of difference, the specific terms prevail.
Access FDA provides private regulatory consulting services grounded in the Code of Federal Regulations (CFR), FDA requirements and applicable regulation. Access FDA is not an authority and is not affiliated with the FDA.
Client obligations
- Provide truthful, complete and up-to-date information, and deliver documents on time.
- Review and approve the documents submitted on its behalf.
- Report promptly any change in its company, facility, products or importers that affects the service.
- Pay for the services according to the accepted proposal.
The Client is responsible for the accuracy of the information it provides. Delays or errors resulting from incomplete or inaccurate information are not attributable to Access FDA.
Access FDA obligations
- Provide the services with professional diligence, within the contracted scope.
- Keep information confidential under the Mutual Non-Disclosure Agreement (NDA) and the Comprehensive Privacy Notice.
- Inform the Client of the regulatory requirements identified and the next steps.
- Answer the Client’s questions without limit within the contracted scope.
Fees and payments
Fees are set in the accepted proposal. Unless the proposal states otherwise:
- services are valid for 12 months from payment;
- payments are non-refundable, as a commercial decision, without prejudice to any rights applicable law grants the Client;
- fees do not include third-party duties, fees or charges (laboratories, authorities, customs brokers, travel), unless expressly stated.
[Pending: applicable taxes, invoicing methods and installment conditions.]
Term and renewal
Services expire 12 months after payment. Renewal conditions for FDA Establishment Registration and the U.S. Agent service are described in their specific terms and do not extend to other services.
Limits of liability
Regulatory decisions belong to the authorities. Access FDA does not promise product approval, acceptance of filings, release of shipments, border crossing or commercial results. Access FDA’s liability is limited to the diligent provision of the contracted services. [Pending: liability cap, if any.]
Official communications
Communications about the services take place only through management@gruponativot.com and the official phone and WhatsApp +52 33 1125 7553. Access FDA will not request payments or documents through any other channel.
Confidentiality and personal data
The Client’s information is protected under the Mutual Non-Disclosure Agreement (NDA) and the Comprehensive Privacy Notice.
Logos and testimonials
Access FDA will only publish client logos, names or testimonials with prior written authorization. That authorization does not extend to formulas, trade secrets, technical information or confidential documentation.
Registration numbers and documents
Registrations and numbers obtained from authorities belong exclusively to the identified entity, establishment or product. Private documents issued by Access FDA state their private nature and may not be assigned, resold, modified or presented for another entity, nor presented as issued or approved by the FDA without express official support.
Termination
[Pending: grounds and effects of early termination.]
Governing law and jurisdiction
[Pending: governing law and competent courts.]