Nutraceutical & Herbal Clinical Research Services
Regulatory agencies and retailers increasingly require clinical substantiation of nutraceutical health claims. Genelife Clinical Research provides specialized nutraceutical clinical research services in India — combining pharmaceutical-grade clinical trial methodology with deep understanding of nutraceutical and herbal product regulations.
FSSAI · AYUSH · EU Regulation 1924/2006 · FDA DSHEA — Our nutraceutical research is designed to meet claim substantiation requirements of all major global regulatory frameworks.
Analysis
Design
Trial
Dossier
Clinical Validation Studies
Clinical validation is the gold standard for nutraceutical claim substantiation. Our studies are designed to generate robust, peer-reviewable evidence across diverse therapeutic and wellness categories.
Randomized Controlled Trials (RCTs)
Gold-standard double-blind, placebo-controlled randomized trials for nutraceuticals — generating the highest quality evidence for health claim substantiation, conducted per ICH-GCP guidelines with full biostatistical support.
Observational & Open-Label Studies
Pragmatic observational studies, open-label trials, and real-world evidence generation for nutraceuticals — appropriate where blinding is not feasible or for early-stage product validation.
Herbal & Ayurvedic Product Trials
Clinical evaluation of herbal formulations, Ayurvedic preparations, and botanical extracts — including safety profiling, efficacy assessment, and AYUSH regulatory compliance documentation.
Biomarker & Laboratory Assessments
Clinical chemistry, haematology, hormonal assays, inflammatory markers, glycaemic indices, lipid profiles, and micronutrient assessments — supporting evidence-based health claims.
Therapeutic Areas
Immunity & General Wellness
Immune modulation studies, antioxidant activity, and wellbeing evaluations for immunity boosters, multivitamins, and adaptogens.
Bone & Joint Health
Bone mineral density, joint mobility, pain scores, and cartilage biomarkers for calcium, vitamin D, collagen, and joint health products.
Cognitive & Brain Health
Neuropsychological assessments, cognitive performance testing, and stress biomarkers for nootropics, omega-3, and memory support supplements.
Cardiovascular & Metabolic
Lipid profile, glycaemic control, blood pressure, and body composition studies for heart health, diabetes support, and weight management products.
Women's Health
Hormonal balance, menopausal symptom assessment, and reproductive health evaluations for women's wellness and herbal formulations.
Gut Health & Probiotics
Gut microbiome analysis, digestive symptom scoring, and bowel function assessment for probiotic, prebiotic, and digestive health products.
Sleep & Stress
Validated sleep quality scales (PSQI), cortisol measurement, and stress assessment for sleep support, adaptogen, and anti-stress nutraceuticals.
Sports & Performance Nutrition
Physical performance testing, body composition analysis, endurance and strength assessment for sports nutrition and protein supplements.
Paediatric & Maternal Nutrition
Growth and developmental assessments, nutritional status evaluations, and maternal health studies for infant nutrition and prenatal supplements.
Claim Substantiation
We help brands translate clinical data into defensible, approved marketing claims across all major regulatory frameworks.
Health Claim Dossier Preparation
End-to-end preparation of health claim substantiation dossiers for FSSAI (India), EFSA (EU), FDA (USA) — including systematic literature review, clinical evidence summary, and claim wording recommendations.
Systematic Literature Review (SLR)
Comprehensive review of published scientific literature supporting your product's active ingredients — identifying existing clinical evidence, gaps, and opportunities for additional research.
Regulatory Claim Wording
Expert guidance on permissible claim language under FSSAI, AYUSH, EU Regulation 1924/2006, and DSHEA — ensuring claims are compelling and regulatory-compliant.
Label Compliance Review
Review of product labels and marketing materials for compliance with applicable nutraceutical regulations — helping brands avoid regulatory action while maximizing claim impact.
GAP Analysis
Before investing in clinical research, understanding what evidence already exists — and what is missing — is essential. Our GAP Analysis provides a strategic roadmap for your product's clinical development.
Evidence GAP Analysis
Comprehensive assessment of existing scientific and clinical evidence for your product's active ingredients — identifying what data is available, what claims it supports, and what studies are needed for additional claims.
Regulatory GAP Analysis
Assessment of your product's current regulatory status versus requirements of your target markets — identifying documentation gaps, missing safety data, or additional testing requirements.
Competitive Benchmarking
Analysis of the clinical evidence base supporting competitor products — identifying differentiation opportunities and helping prioritize your clinical investment strategically.
Clinical Development Roadmap
A prioritized, costed clinical development plan — outlining the most efficient path from your current evidence position to the claims you want to make, with realistic timelines and budget estimates.
Deliverables
- Clinical Study Report (CSR) — full GCP-compliant report suitable for regulatory submission
- Health Claim Substantiation Dossier — FSSAI, EFSA, FDA ready
- GAP Analysis Report — evidence review and clinical development roadmap
- Systematic Literature Review — comprehensive scientific evidence summary
- Biostatistical Analysis Report with appropriate methodology for nutraceutical studies
- Regulatory Submission Support — FSSAI product approval and AYUSH registration assistance
- Publication Support — scientific manuscript preparation for peer-reviewed journals
Why Genelife for Nutraceutical Research? We bring pharmaceutical-grade clinical trial rigour to nutraceutical research — GCP-trained teams, validated biomarker assessments, biostatistical expertise, and deep regulatory knowledge of FSSAI, AYUSH, EU, and FDA frameworks — from a CDSCO-registered CRO in India.