Regulatory Compliance Setup Package for Brand Owners

One-Time Project-Based Setup – Covers FDA Compliance Without Ongoing Oversight

This setup package helps brand owners build a fully documented compliance framework aligned with U.S. FDA requirements. It includes supply chain controls, product compliance programs, and optional FSVP documentation for importers. Designed for businesses that outsource manufacturing but must maintain regulatory readiness.

Who this is for

Brand owners (U.S. or international) who:

• Rely on co-manufacturers, packers, or private labelers
• Need a compliant quality system without operating a production facility
• Import food, beverages, or supplements (FSVP may apply)
• Require documentation for audits, distributor requests, or FDA inspections

Scope of Work

A. Supplier and Contract Manufacturer Management

1. Supplier Approvals – 21 CFR 117.410

• Develop SOPs for approval, monitoring, and re-evaluation of supplier (local and/or foreign), tailored to the client’s current processes.
• Perform full assessment of the supplier’s documentation as part of verification and approval.
• Set up a supplier evaluation checklist and status tracker.

2. Specifications Management – 21 CFR 117.475

• Develop specification templates for raw materials, packaging, and finished products.
• Align specifications with the relevant regulations, and/or the contract manufacturer’s product development and release protocols.

3. Internal Audit Program for Co-Manufacturer Oversight – 21 CFR 117.435

• Provide internal audit SOP and schedule template for reviewing contract manufacturers and off-site production oversight.
• Customize the programs and procedures to the client’s contractor evaluation processes.

4. Co-Manufacturing Quality Agreements – 21 CFR 117.335

• Draft a standard quality agreement template for use with contract manufacturers.
• Include clauses for production standards, deviation handling, and change notifications.

5. Food Fraud Vulnerability Assessment (FFVA) – 21 CFR 121.130

• Provide assessment record tools for ingredient and supplier fraud risks.
• Include customized SOPs for periodic review and mitigation strategy documentation.
• Perform vulnerability assessments on product/s and identify actionable process steps and mitigation strategies according to 21 CFR 121.126 to 121.135.

6. Records Retention Program – 21 CFR 117.315

• Set up SOPs and filing system guidance for creation, retention, and archiving of records and documentation, including document control logs and record access control guidance tailored to the client’s current processes.

B. Product Compliance and Risk Programs

1. Label and Product Version Control

• Develop SOPs and checklists to manage compliance monitoring and revisions of product labels, packaging specs, and supporting artwork.

2. Traceability Program – 21 CFR 1.1315 (FSMA Traceability Final Rule)

• Provide traceability SOP and example records for ingredients and finished goods.
• Customize records to product type/s handled within the facility.

3. Product Withdrawal and Recall Program

• Develop a customized recall plan including notification procedures, roles, and mock recall forms.

4. Customer Complaint Program – 21 CFR 117.410(e)

• Set up a customized SOP and log template for complaint handling, investigation, and trend analysis.

5. Crisis Management Program – 21 USC 301

• Provide emergency response programs covering mitigation and/or addressing food safety/security issues.
• Include checklists for communication, escalation, and recovery.

6. Basic HACCP or Food Safety Plan Template

• Develop templates covering the elements of the food safety plan, such as hazard identification, flow diagram, critical control points and preventive control identification/monitoring, and corrective action logs.

C. Optional: FSVP Compliance Setup (if importing products into the USA)

1. Foreign Supplier Verification Program – 21 CFR 1.502

• Develop a customized FSVP policy and documentation structure for brand owners defined as FSVP importers.

2. Foreign Supplier Evaluation

• Provide importer-side evaluation forms aligned with FSVP risk-based activities.

3. Temporary FSVP Policy for Emergency Suppliers

• Draft a customized procedure for emergency sourcing approvals

4. Food Defense Plan Form

• Provide recordkeeping tools to help assess facility-level defense measures of foreign suppliers

5. FSVP Importer Registration Assistance (if applicable)

• Provide guidance or advice in relation to FDA food/supplement importer facility registration applications/renewals, if any.

Deliverables

Customized SOPs and Compliance Documents

• Includes the following: Foreign Supplier Verification SOPs, Supplier Audit Procedures, Risk Analysis Matrix, Product Specification Templates, Food Defense SOPs, Recall SOPs, HACCP/Food Safety Plan, Written Assurance Forms, and Traceability Forms.

Audit and Verification Reports

• Supplier evaluation report with risk scoring, justification for approval status, and summary of verification methods used (onsite audit, COA review, questionnaire, etc.)
• Risk assessment report for food fraud vulnerability
• Comprehensive set of audit forms and training materials used for supplier verification and compliance evaluation. Includes Audit Templates and Reports, Supplier Evaluation Scorecards, and Food Safety Compliance Risk Logs to support regulatory readiness and continuous improvement.

Records Management

• Covers critical documentation control, including Documentation Logs, Version-Controlled Record Indexes, and Annual Review Checklists to ensure traceability and accountability.

Label Compliance Assessment

• This service provides internal tools—not a regulatory review—for identifying labeling non-conformances and tracking revisions. It includes structured forms and assessment checklists such as Product Label Review Forms and Identity Compliance Checklists, helping teams evaluate labels against FDA requirements and maintain accurate, up-to-date product information.

Training Package by TrainingAce.pro

• Includes comprehensive training materials such as lessons and comprehension quizzes, designed to support internal training requirements and enhance staff awareness.

FSVP Compliance Package (if applicable)

• Complete, customized FSVP Program available in digital and/or print format. The package contains all required SOPs, company-specific policies, and verification forms essential for meeting FDA regulatory compliance requirements.

Client Engagement Support

• Client engagement tools include SOP Client Presentation Decks, Meeting Summaries, and Change Request Logs to facilitate collaboration and feedback throughout the implementation process.

Pricing and Timeline

Setup Tier	Timeline	Price
Standard Brand Owner Setup (w/o FSVP Requirements) for 1 local supplier and 1 product	60 to 75 business days	$4,800 per facility
Importer-Brand Owner Setup (w/ FSVP Requirements) for 1 foreign supplier and 1 product	70 to 80 business days	$5,950 per facility
Add-on: Supply-chain/FSVP Compliance Assessment for additional supplier/s	5 to 10 business days	+ $249 per additional supplier
Add-on: FFVA Set-up for additional product/s	5 to 10 business days	+ $129 per additional product
Add-on: Supply-chain/FSVP and FFVA Set-up for 2 or more suppliers and/or products	Varies	Custom quote
Add-on: Monthly Brand Owner Full Compliance Support	–	Starts at $2,500 per month

Ready to Get Compliant?

Whether you are launching a new product or aligning an existing brand with FDA requirements, our Brand Owner Compliance Setup Package gives you a turnkey, audit-ready documentation system—customized to your product and supplier. Contact us today to get started or request a tailored proposal. Our team will guide you through each step and ensure your setup meets U.S. regulatory expectations with confidence.