General Compliance Services

Your Trusted Partner for Regulatory Compliance—Whenever You Need It

This service provides structured, on-demand support to help your facility meet domestic and international food safety and regulatory requirements with confidence. It covers key areas such as regulatory guidance, compliance program development, risk assessment, internal auditing, and documentation review—ensuring your operations are audit-ready, risk-aware, and aligned with market-specific standards.

Scope of Work

Regulatory Guidance and Interpretation (e.g., US FDA, USDA, EU, Asia-Pacific, Africa, Latin America)

• Interpretation and clarification of applicable rules and changes • Customized guidance for markets such as U.S. (FDA, USDA, FSMA, FSVP); EU (EFSA, FSA); Asia-Pacific (e.g., CFDA, FSSAI, Singapore Food Agency); Africa (e.g., NAFDAC, SABS); Latin America, and other key regions
• Frequency: As requested (minimum quarterly regulatory change check)

Compliance Program Development and Improvement

• Design, revision, or optimization of facility-specific compliance programs • Alignment with regulatory and buyer-specific requirements across target markets • Frequency: Up to 2 custom program developments or revisions per membership year (project-based)

Risk Assessment and Management

• Conduct risk assessments for products, materials, processes, or suppliers • Recommend mitigation measures and monitoring plans • Frequency: Up to 2 assessments annually; brief risk reviews available on demand

Internal Audits and Assessments

• Develop and/or perform internal audits and gap assessments in line with export market and buyer standards (e.g., GMP, HACCP, FSMS, ISO, GFSI) • Identify gaps prior to customer or regulatory audits • Frequency: Annual internal audit of up to 1 program included; additional audits redeemable via rollover credits

Regulatory Change Management

• Monitor and communicate any relevant regulatory changes • Assess impact on your operations; recommend necessary updates • Frequency: Quarterly monitoring with alerts issued as needed

Compliance Documentation Review

• Review SOPs, policies, and records for regulatory adequacy and completeness, and provide recommendations on areas needing updates • Ensure readiness for audits and inspections • Frequency: Up to 4 programs/procedures/records reviewed per year (monthly document Q&A available)

Customized Consultation Services

• Case-by-case consulting for unique business or operational needs • Problem-solving support during supplier, customer, or regulatory inquiries • Guidance and coaching on the conduct various compliance activities • Frequency: On demand within monthly 4-hour service allowance

Deliverables

The following deliverables may include:

• FDA Facility Registration Confirmation • U.S. Agent Designation Letter (foreign facilities) • Optional Certificate of FDA Registration (for presentation use) • USDA Establishment Application (if applicable) • D-U-N-S® Number Confirmation (new or updated) • Facility Compliance Checklist • Product Classification & Jurisdiction Advisory Report • FSVP Agent Designation Confirmation (basic level) • Biennial Renewal and Compliance Monitoring Setup

Actual deliverables also vary depending on the Client’s requests and needs. The deliverables enumerated above are advisory in nature and intended to guide and support the Client’s development, implementation, and maintenance of regulatory compliance systems.

Your Compliance Support, Simplified and Structured

• Monthly Service Allowance: 4 expert hours/month included • Rollover Credits: Unused hours are carried over to the next month, and may be converted to service credits for larger projects • Redeemable for compliance activities such as: ∟ Gap assessments ∟ Label reviews ∟ Emergency regulatory response ∟ Complex risk assessments ∟ Program development, reviews, and re-writes

Annual Compliance Plan Example

Quarter 1 (Q1): • Action: Regulatory change review + Risk update • Deliverables: Change impact report, updated risk matrix (if applicable) • Frequency: Annually (Q1) Quarter 2 (Q2): • Action: Internal audit (e.g., FDA/USDA or general GMP compliance) • Deliverables: Completed audit report, Corrective Action Plan (CAP) list • Frequency: Annually (Q2) Quarter 3 (Q3): • Action: Standard Operating Procedure (SOP) review (up to 2 procedures) • Deliverables: Review findings, update recommendations • Frequency: Annually (Q3) Quarter 4 (Q4): • Action: Compliance program review and revision (if needed) • Deliverables: Review findings, program revision, summary of changes (if applicable) • Frequency: Annually (Q4) Monthly: • Action: Advisory calls, on-demand support, minor document reviews • Deliverables: Q&A responses, compliance subscription tracking, coaching and guidance materials • Frequency: 4 hours per month (with rollover available)

Why this works for your business

• Budget-Friendly - No surprise invoices; control compliance costs year-round. • Crisis-Ready - Immediate expert access when inspection findings or supplier demands arise. • Rollover Value - Unused hours are not lost—save them for intensive audits or gap assessments.

Key Member Benefits

✔ Fixed Costs - Predictable monthly investment
✔ Risk Control - Prevent non-compliance, regulatory violations, and gaps
✔ Knowledge Growth - Documentation, SOPs, and training enhanced over time

Fees and Subscriptions

Package	Fee (USD)	Action
General Compliance Services	$99.00 (monthly subscription)	Subscribe

Because effective compliance is not just meeting requirements; it also safeguards your products, customers, and brand reputation.