Regulatory Consulting Services
Clarity in compliance. Confidence in execution.
We help food businesses, manufacturers, retailers, and laboratories navigate the evolving U.S. and global regulatory landscape with precision, strategy, and measurable outcomes.
Our Expertise
We offer end-to-end regulatory support across the product lifecycle—from concept to commercialization—ensuring your operations meet the highest standards of safety, legality, and market readiness.
Regulatory Strategy & Roadmapping
- Product classification and jurisdiction mapping (FDA, USDA, EPA, FTC)
- Regulatory pathway analysis for new products, ingredients, or technologies
- U.S. and international market entry planning (Codex, EU, Canada, ASEAN)
Compliance Gap Assessments
- Facility and documentation audits against FSMA, 21 CFR, ISO 22000, and GFSI benchmarks
- Risk-based evaluations of labeling, claims, traceability, and supplier controls
- Actionable remediation plans with timelines and resource guidance
Regulatory & Labeling Advisory
- FDA/USDA compliance reviews
- Nutrition labeling and claims substantiation (21 CFR 101)
- Import/export documentation and Codex alignment
- GRAS, food additive, and dietary supplement submissions
Labeling & Claims Review
- Nutrition Facts Panel (NFP) compliance under 21 CFR 101
- Allergen declarations, ingredient statements, and font/format validation
- Substantiation of nutrient content, structure/function, and qualified health claims
- FTC-compliant advertising and digital content review
Regulatory Submissions & Dossiers
- GRAS notifications, food additive petitions, and color additive approvals
- Dietary supplement NDI notifications and structure/function claim submissions
- ISO 17025 accreditation support for analytical labs (quality manual, SOPs, method validation)
- Technical file preparation for import/export (FDA Prior Notice)
Inspection & Audit Readiness
- FDA and USDA inspection preparedness (mock inspections, 483 response support)
- GFSI scheme alignment (BRCGS, SQF, FSSC 22000)
- FSMA Preventive Controls and Foreign Supplier Verification Program (FSVP) compliance
- Recall simulation and traceability stress testing
Regulatory Intelligence & Monitoring
- Real-time tracking of regulatory updates (Federal Register, Codex, EFSA, Health Canada)
- Impact assessments for proposed rule changes
- Customized alerts and compliance bulletins for your product category
Risk & Root Cause Analysis
- Environmental monitoring program design
- Trend analysis of pathogen and indicator data
- Root cause investigations and CAPA planning
- Supplier risk assessments and verification protocols
Training & Capacity Building
- Customized workshops for HACCP, GMP, ISO, and lab best practices
- On-site or virtual training for QA/QC teams
- SOP development and technical writing support
Why Choose Us?
- Multidisciplinary expertise: Food scientists, regulatory specialists, and quality professionals under one roof
- U.S. and global fluency: Deep knowledge of FDA, USDA, FSIS, FSQMS EPA, and Codex frameworks
- Tailored solutions: We adapt to your product, pr, ocess, and market—not the other way around
- Beyond compliance: We help you build systems that are audit-ready, scalable, and resilient
Who We Serve
- Food & beverage manufacturers (RTE, dairy, bakery, beverages, supplements)
- Third-party and in-house laboratories (ISO 17025, method validation, QA systems)
- Importers/exporters navigating U.S. and international food regulations
- Startups launching novel ingredients or functional foods
- Retail brands seeking label compliance and claim substantiation
Leading food testing laboratory ensuring safety and quality in the food industry.
Contact Us
9341 E.Childs Ave., Planada, CA 95365, USA.
operations@fsa-lab.com
info@fsa-lab.com
support@fsa-lab.com
Office 1 : (209) 877 8728 Office 2 : (209) 877 8729