Food Post-Market Surveillance & Consumer Safety Services for Nutraceuticals and Food Supplements
Our Food Safety Vigilance Services provide comprehensive monitoring, risk assessment, and compliance solutions to help businesses navigate the evolving regulatory landscape and ensure consumer safety.
Ensuring the safety, efficacy, and regulatory compliance of nutraceuticals, food supplements, and functional foods is crucial for consumer health and market acceptance. With the increasing global regulatory scrutiny on food safety and post-market monitoring, companies must adhere to stringent health authority guidelines, including ICH, US FDA, EMA (Europe), GCC, and other regulatory bodies.
Regulatory Framework for Food Post-Market Surveillance
Our services align with the latest regulatory requirements for nutraceuticals, dietary supplements, and functional foods across major health authorities:
✅ ICH (International Council for Harmonisation) Guidelines – Pharmacovigilance & Risk Management for nutraceutical safety
✅ US FDA (Food and Drug Administration) Regulations – 21 CFR Part 111 (Current Good Manufacturing Practices for Dietary Supplements) & 21 CFR Part 117 (Food Safety Modernization Act)
✅ EMA (European Medicines Agency) & EFSA (European Food Safety Authority) – Compliance with Regulation (EC) No 178/2002 and novel food safety evaluations
✅ GCC (Gulf Cooperation Council) Guidelines – SFDA, UAE MOH, and Qatar Ministry of Public Health regulations for dietary supplements
✅ Codex Alimentarius – International food safety standards for global trade
✅ FSSAI (Food Safety and Standards Authority of India) – Compliance with food supplement and nutraceutical regulations
Our Comprehensive Food Safety Vigilance & Post-Market Surveillance Services
- Post-Market Monitoring & Adverse Event Reporting
✔️ Real-world safety monitoring of food supplements and nutraceuticals
✔️ Adverse event (AE) detection, tracking, and reporting in compliance with global regulatory requirements
✔️ Benefit-risk assessment for consumer safety
- Contaminant & Risk Assessment Studies
✔️ Heavy metal & toxin analysis (Lead, Arsenic, Mercury, Cadmium)
✔️ Pesticide residues & mycotoxins evaluation
✔️ Microbiological testing for bacterial, fungal, and viral contaminants
- Food Fraud & Adulteration Detection
✔️ Screening for undeclared ingredients, harmful additives, and adulterants
✔️ Verification of authenticity and purity of botanical extracts and functional ingredients
✔️ DNA testing for ingredient identity confirmation
- Nutritional & Labelling Compliance Reviews
✔️ Validation of health and nutrition claims (e.g., “boosts immunity,” “supports weight loss”)
✔️ Compliance with EU Health Claims Regulation (EC) No 1924/2006
✔️ FSSAI & US FDA dietary supplement labelling requirements
- Pharmacovigilance & Safety Surveillance for Nutraceuticals
✔️ Post-marketing risk assessment and toxicology studies
✔️ Long-term consumer safety monitoring
✔️ Scientific substantiation of functional claims for regulatory approvals
- Clinical & Observational Studies for Nutraceuticals
✔️ Phase IV (Post-Marketing) clinical trials for dietary supplements
✔️ Real-world evidence (RWE) generation to support safety claims
✔️ Consumer perception & acceptability studies
- Ingredient Safety & Novel Food Evaluations
✔️ Assessment of new food additives, probiotics, and functional ingredients
✔️ Novel food compliance under EU Novel Food Regulation (EC) No 2015/2283
✔️ GRAS (Generally Recognized as Safe) evaluations for US FDA submissions
- Compliance with Good Manufacturing Practices (GMP) & Quality Audits
✔️ GMP compliance audits for manufacturing & supply chain integrity
✔️ Facility inspections and quality control assessments
✔️ Development of Standard Operating Procedures (SOPs) for food safety compliance
Why Choose Us for Food Safety Vigilance & Post-Market Surveillance?
🔹 Regulatory Expertise – Deep knowledge of ICH, FDA, EMA, GCC & FSSAI compliance requirements
🔹 Advanced Testing Facilities – Accredited labs for chemical, microbiological, and toxicological assessments
🔹 End-to-End Compliance Support – Covering pre-market approvals to post-market surveillance
🔹 Global Reach – Supporting compliance in North America, Europe, MENA, and Asia-Pacific regions
🔹 Risk-Based Approach – Ensuring proactive monitoring & early detection of safety risks
Ensuring the post-market safety of nutraceuticals and food supplements is essential for regulatory compliance, brand reputation, and consumer trust. Our scientifically driven and globally compliant food safety vigilance services help you meet strict health authority standards while safeguarding public health.
📩 Contact us today to ensure regulatory compliance and consumer safety for your food supplements & nutraceutical products!
