Nutraceutical CRO In India
- Clinical efficacy and safety assessment
- Label claims
Nutraceutical Clinical Research & Claims
In the fast-paced and evolving nutraceutical marketplace, it is vital for supplement producers and wellness organizations to substantiate their claims with quality, evidence-based research. As regulators focus on compliance and consumers demand visibility, it becomes easy for organizations to differentiate themselves by utilizing well-structured research to validate each claim and turn it into a trustworthy and reliable statement.
At BioAgile Therapeutics, we understand nutraceutical brands want to do more than just comply with regulation – they seek to deliver real value and trust to their consumers. To ensure your claims are legitimate, compliant with FSSAI rules and regulations, and in accordance with international standards, BioAgile Therapeutics offers bespoke research solutions for performing nutraceutical clinical trials that combine scientific rigour with consumer relevance.
Simplifying Claims Validation
Not all claims carry the same regulatory weight. Claims are classified by authorities to determine their potential impact on health and consumer expectations:
At BioAgile, we assist clients with ensuring their proposed label claims uses the correct terminology and is supported by the appropriate level of evidence. This ensures that your brand is able to confidently and compliantly convey product benefits
Advanced Testing Methodologies – Clinical designs
Designs of Clinical Trials for Nutraceutical Investigations-
Creating reliable evidence for nutraceutical claims requires careful consideration of trial design. We at BioAgile customize research based on your product, the nature of your claims.
Regulatory Confidence – Ethical & Transparent Research
BioAgile Therapeutics offers integrated regulatory support to ensure your products meet regulatory requirements across the globe:
EFSA Health Claims Pathway Knowledge
Support for developing scientifically substantiated claims under European Food Safety Authority (EFSA) frameworks.
International Market Access Support – Regulations Guidance
End-to-end research and documentation solutions to facilitate gaining acceptance of your nutraceutical products across multiple regulatory regions.
FSSAI Compliance Expertise
Guidance on claim validation, study design, and dossier preparation as per Indian food regulations.
FDA Dietary Supplement Regulations Guidance
Assistance with clinical research and documentation aligned with U.S. FDA expectations for dietary supplements.
Ethical & Transparent Research
Compliance with regulatory norms.
Transparent documentation and traceable data for audits and submissions.
Ethical, consumer-focused study execution.
Trusted By
Consumer Insights that matter
Understanding consumer perception is essential to build trust and market relevance. BioAgile Therapeutics combines comprehensive consumer-focused assessments with clinical research to support holistic product positioning:
These insights bridge scientific validation with consumer experience—ensuring the product is both efficacious and desirable.
Proven Success Stories – Case Snapshot
Study Title: Lutein and Zeaxanthin Supplementation Improves Dynamic Visual and Cognitive Performance in Children: Randomized, Double-Blind, Parallel, Placebo-Controlled Study
Published In: Advances in Therapy, Volume 41, Pages 1496–1511 (2024)
This randomized, double-blind, placebo-controlled trial aimed to determine the effects of lutein (10 mg), and zeaxanthin (2 mg) supplementation on the visual and cognitive abilities of preadolescent children aged 5 to 12 years using gummies over a 180-day study.
https://link.springer.com/article/10.1007/s12325-024-02785-1
Study Title: Natural Sports Supplement Formulation for Physical Endurance: Randomized, Double-Blind, Placebo-Controlled Study
Published In: Sport Sciences for Health, Volume 13, Issue 1, Pages 183–194 (2017)
The purpose of this randomized, double-blind, placebo-controlled trial was to assess how FitnoxTM, formulation that contains extracts of Moringa oleifera leaves, Punica granatum peel, and Kaempferia parviflora root, affected the physical endurance of healthy adult males. The supplement was given for a total of twenty-two days.
https://link.springer.com/article/10.1007/s11332-017-0352-y
Study Title: Acujoint™, a Highly Efficient Formulation with Natural Bioactives, Exerts Potent Anti-Arthritis Effects in Human Osteoarthritis – A Randomized Clinical Study
Published In: Journal of Herbal Medicine, Volume 17–18, Article 100276 (2019)
This single-center, double-blind, randomized, active-controlled clinical trial evaluated the safety and efficacy of AcujointTM in individuals suffering with mild to moderate osteoarthritis. AcujointTM (250 mg/day) or a control medication consisting of glucosamine (1500 mg) and chondroitin (1200 mg) was administered to 24 individuals over a period of 90 days.
https://www.sciencedirect.com/science/article/pii/S2210803319300223