This blog highlights the unique challenges and opportunities in the nutraceuticals and consumer products sector. The term “nutraceuticals” remains without an officially recognized and universally accepted definition. Often referred to as “pharma-foods,” nutraceuticals occupy a unique space—used beyond the scope of traditional diets yet not fully classified as drugs. Clinical validation of their safety, mechanisms of action, and efficacy is critical to building trust and ensuring the long-term growth of the nutraceuticals market.

However, navigating this grey area presents challenges. Differences in international regulations and legislation create hurdles, particularly concerning safety standards and health claim substantiation. These factors underscore the importance of robust clinical trials and evidence-based claims to succeed in the market for nutraceuticals and consumer products.

At Lambda Therapeutic Research, a full-service global CRO, we provide comprehensive solutions tailored to the nutraceuticals and consumer products sector. From designing and executing clinical studies to substantiating advertisement claims and supporting product registration, we ensure your product stands out in a competitive market. Trust us for safety, efficacy, and regulatory compliance—cornerstones for thriving in the dynamic nutraceuticals space.

Capabilities

We specialize in conducting clinical studies for a diverse range of Nutraceuticals and Consumer Products, including over-the-counter (OTC) items, hair regrowth products, skin & personal hygiene products, de-addiction therapies, health supplements, and fortified food products such as oils, flours, and milk-based ingredients. Our comprehensive services ensure safety, efficacy, and regulatory compliance for all product categories.

Nutraceuticals and Consumer Products – Experience

Our extensive experience in conducting clinical trials for nutraceuticals and consumer products ensures reliable, accurate, and regulatory-compliant results. We provide tailored solutions for bioavailability, bioequivalence, efficacy, and safety studies, leveraging state-of-the-art infrastructure and a dedicated team of experts.

	Nutraceuticals	Oral Care	Skin & Hygiene
Study Types	Different types of Rice preparations, Tofu, Flatbread, Wheat Flour, Edible oil	Mouth wash, Toothbrush, Tooth-paste	Sanitizer, Skin Cream, Soap, Liquid Soap
Endpoints	Insulin, Sugar, C-peptide	Anti-bacterial, Anti-malodour, Anti-oxidant efficacy	Skin whitening, Anti-bacterial efficacy
No of Studies: 132	9	82	41

Executed Methods

We utilize a wide range of advanced methodologies to assess the efficacy and performance of nutraceuticals and consumer products in key areas:

Lambda’s Approach – Overcoming Challenges in Nutraceuticals & Consumer Products

Navigating the Unique Challenges of Nutraceutical & Consumer Product Clinical Studies demands tailored solutions. At Lambda, we understand the complexities, providing precise trial designs that address the multifaceted nature of nutraceuticals & consumer products.

Strategic Endpoint Selection: Selecting endpoints and biomarkers for these studies is a nuanced process. Lambda’s approach involves a meticulous analysis to ensure relevance and reliability, overcoming the challenge of multiple potential benefits.

Pilot Studies for Informed Trials: To gain insights into desired outcomes, Lambda advocates strategic pilot studies, reducing costs and time investment. This approach enhances the precision of clinical trials, setting the stage for success.

Addressing Lifestyle Influence: Lambda recognizes the significant impact of lifestyle choices on nutraceutical outcomes. Our trial designs account for this influence, ensuring robust data collection and overcoming challenges in recruitment.

Patient Retention Excellence: Lambda’s experience ensures effective trial management, mitigating challenges like higher dropout rates. By streamlining demands on participants and utilizing proven strategies, we enhance patient retention for successful nutraceutical studies.

Discover the Lambda Advantage – Where Expertise Meets Excellence

Embark on a journey of innovation and success with Lambda. Our precision in trial designs, stringent quality control, excellence in patient retention and robust data collection, ensure your nutraceutical & consumer product studies transcend challenges.

Connect with our experts at BD@lambda-cro.com to leverage the extensive end-to-end capabilities of Lambda & Novum.

About Lambda

Lambda & Novum delivers full-service CRO services to the innovator, biotech, and generic pharmaceutical industries worldwide. With a strong global presence in India, the USA, Canada, the UK, Barcelona (Spain) and Poland, we bring specialized expertise to every project. Our focus on secure IT infrastructure and automation ensures timely project delivery and strict adherence to international regulatory standards. Lambda’s exemplary regulatory track record includes over 60 successful inspections and audits by esteemed authorities, including the USFDA, EMEA, MHRA, EU member states, and other global regulatory bodies, in the past five years.

Lambda’s commitment to excellence has garnered significant recognition, including the ‘Best Indian CRO’ award from Frost & Sullivan (USA) and the ‘Great Indian Workplace’ title from UBS Transformance. Recent accolades include the ‘Regulatory Excellence’ Award at the CPhI Pharma Awards 2023 and the ‘Industry Partner of the Year’ Award at the Global Generics & Biosimilar Awards 2023.

References:

• https://pmc.ncbi.nlm.nih.gov/articles/PMC5867125/