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Regulatory Compliance Technical Advisory Services

Structured Regulatory Interpretation for U.S. Market Entry Planning

This service provides structured technical advisory support for businesses requiring professional interpretation of U.S. regulatory requirements, including Foreign Supplier Verification Program (FSVP) obligations under 21 CFR 1 Subpart L and related FDA regulatory frameworks.

The engagement is consultative and non-representational in nature. Guidance is intended to support the Client’s internal compliance planning and decision-making and does not constitute regulatory approval, certification, or delegated compliance responsibility.

Clients are provided access to an FSVP Qualified Individual (QI) for regulatory clarification and compliance direction.

Scope of Work

Regulatory Guidance & Interpretation

  • Clarification of FDA Foreign Supplier Verification Program (FSVP) regulatory requirements under 21 CFR 1 Subpart L
  • Interpretation of FDA guidance documents, warning letters, enforcement trends, and inspection expectations
  • High-level identification of importer, manufacturer, and supply-chain regulatory responsibilities
  • Advisory overview of regulatory pathways affecting U.S. market entry
  • Identification of typical approvals, permits, or notifications that may apply
  • Review of publicly available statutes, guidance, and regulatory frameworks for interpretation support

FSVP Program Advisory

  • High-level guidance regarding:
    • Hazard analysis expectations
    • Supplier approval considerations
    • Verification activity concepts (COAs, audits, testing)
    • Corrective action expectations
  • Advisory feedback on existing FSVP approaches
  • Discussion support prior to potential FDA interactions (non-representation)

Supplier and Product Advisory

  • Advisory discussion of supplier documentation expectations
  • Product-specific regulatory risk considerations
  • Import readiness considerations (pre-shipment planning only)
  • Identification of commonly requested documentation during regulatory review

Documentation Review (Non-Certifying)

Where provided by the Client, available documents may be reviewed for general completeness and consistency from an advisory perspective.
The Company does not authenticate, certify, validate, or approve documents for regulatory acceptance.



Service Limitations

Services are strictly advisory and consultative. The Company:

  • Does not submit regulatory filings or applications
  • Does not communicate with FDA, USDA, CBP, or authorities on behalf of the Client
  • Does not act as U.S. Agent, Importer, exporter, or regulatory representative
  • Does not create or implement compliance programs
  • Does not guarantee compliance determinations, clearance, or admissibility

The Client retains full regulatory responsibility for compliance, importer coordination, submissions, inspections, and business decisions.

Regulatory Guidance & Interpretation

• Clarification of FDA Foreign Supplier Verification Program (FSVP) regulatory requirements under 21 CFR 1 Subpart L • Interpretation of FDA guidance documents, warning letters, and current inspection and enforcement trends • Advisory support on importer responsibilities, U.S. agent roles, and FSVP importer designation • High-level gap assessment against FDA FSVP compliance and documentation expectations

FSVP Program Advisory

• Guidance on FSVP implementation, including: ◦ Hazard analysis expectations ◦ Supplier approval and qualification criteria ◦ Verification activities (COAs, audits, and testing) ◦ Corrective action expectations • Advisory support for existing FSVP programs • Review of client questions and documentation prior to FDA interactions (non-representation)

Supplier and Product Advisory

• Advisory on foreign supplier documentation • Guidance on product-specific FSVP risks • Recommendations for supplier verification frequency • Import readiness advisory (pre-shipment guidance only)

Note: Exclusions (billed as separate service/s)

• FSVP file creation or drafting • Supplier hazard analysis development or implementation • FDA inspection representation • U.S. Agent services • Shipment approvals or importer sign-off • Corrective action execution • Label compliance reviews • Internal audits and gap assessments

Deliverables

A documented advisory response (email, written summary, or live coaching per agreed hours) outlining:

  • Applicable regulatory framework and reference basis
  • Observed considerations and dependencies
  • Advisory interpretation of the inquiry
  • Recommended next-step considerations

Clarification questions related to the issued advisory may be submitted within the active service period.

• Documented technical advisory (e.g., via documented response, call, or email correspondence) outlining: ◦ Applicable FSVP regulations and reference basis ◦ Assessment and interpretation of the client’s inquiry ◦ Key considerations and recommended next steps • Email support for clarification questions related to the advisory issued

Pricing Structure

Regulatory Guidance and Advisory Services:

Advisory Package Fee (One-time)
Up to 15 hours $350
Up to 50 hours $1,150
Up to 100 hours $2,300
  • Fees are prepaid and non-refundable
  • Service hours are usable within 90 calendar days from payment
  • Work begins after payment confirmation
  • Government and third-party fees are excluded

Exclusions (Separate Services)

  • FSVP file creation or drafting
  • Hazard analysis development or implementation
  • FDA inspection representation
  • U.S. Agent or Importer of Record services
  • Shipment approvals or importer sign-off
  • Corrective action execution
  • Label compliance reviews

Ideal For:

  • Businesses seeking clarity on U.S. regulatory or certification requirements
  • Importers and/or distributors exploring compliance implications prior to importation
  • Manufacturers preparing for audits, certifications, or regulatory verification
  • Organizations that require expert technical interpretation without engaging in full compliance services
  • Clients who submit frequent regulatory questions and prefer a packaged advisory format

If you require professional guidance on any regulatory or certification matter, FSVPServices.com is prepared to assist. Kindly reach out to initiate your advisory engagement or to request an engagement schedule.

• Businesses seeking clarity on U.S. import and FDA FSVP requirements • Importers and/or distributors exploring compliance implications prior to importation • Manufacturers preparing for regulatory verification • Organizations that require expert technical interpretation without engaging in full compliance services • Clients who submit frequent regulatory questions and prefer a packaged advisory format
If you require professional guidance on U.S. importing matters, FSVPServices.com is prepared to assist. Kindly reach out to initiate your advisory engagement or to request an engagement schedule.

Fees and Subscriptions

Package Setup Fee Monthly Maintenance Notes
Amazon Basic Setup $650 N/AAmazon Store Setup only
Amazon Standard N/AStarts at $750/monthEnd-to-end Store Management
Amazon FSVP Package N/ACustom QuoteFSVP Setup + Amazon Setup + Ongoing Store and Compliance Management

Optional Add-Ons:

• FDA Facility Registration: Starts at $550/facility • FSVP Agent Services: starts at $749/year • Label Compliance Review: $750/SKU

Key Benefits

✔ Amazon FSVP compliance documentation handled ✔ Reduce Amazon account suspensions or listing removals ✔ Full FDA compliance support integrated ✔ Peace of mind with expert guidance ✔ Ongoing maintenance to keep Amazon & FDA records up-to-date

Get Started: Contact us at info@consultareinc.com or submit your request via our online form.