Nutraceuticals and Herbals

Nutraceuticals and Herbals services in India

Vipragen, specializing in Non-clinical and Clinical Services Serving Domestic & Global Nutraceutical, Herbal, and Food Supplement Companies for improving safety of products and value enhancement. We perform cutting - edge Claim Substantiation Studies for Demonstrating Product Efficacy through Scientific Research.

Vipragen's Expertise

  • » Expertise in “GRAS” data generation for different agencies like EFSA, US-FDA & MFDS Submission and Dossiers services.
  • » Help in Efficacy tests and regulatory safety & Toxicology studies

Our value to Nutraceutical companies

Specializes in the In vitro & In vivo Studies for Various Indications:

Vipragen is offering pre-clinical services for all the below Product categories

  • » Nutraceuticals
  • » Dietary/Health Supplements
  • » Fitness & Sports
  • » Functional Food
  • » Natural and Herbal Medicine
  • » Personal Care
  • » Pharmaceuticals
  • » Animal Nutrition

Our Services across the value chain

  • » IIn-vitro biological efficacy
  • » In-vivo Pharmacology/Efficacy
  • » ADME/DMPK
  • » Bioanalytical and PK Studies
  • » Immunology Studies
  • » Analytical Testing
  • » Regulatory Toxicology
  • » Genetic Toxicology
  • » Animal Free Testing / In vitro
  • » Claims Studies
  • » Clinical Trials

Efficacy/Claims Studies Across Various Indications

  • » In-vitro biological efficacy
  • » General Health & wellness
  • » Immunity Boosting
  • » Skin Health
  • » Anti-aging
  • » Stress and Anxiety
  • » Obesity
  • » Oncology
  • » Diabetes
  • » Liver Health
  • » Lung Health
  • » Cardiovascular
  • » Heart Health
  • » CNS/Cognition
  • » Quality of Life
  • » Sexual Health
  • » Joint Care

Claims Substantiation – Nutraceuticals, Functional Foods, Food Supplements and Nutricosmetics

Most countries have established regulations and scientific standards to ensure that food labelling claims are expressed correctly and substantiated scientifically.

These regulations and scientific requirements can differ based on various factors, like the type of label claims, the product of interest, their intended use, and country- specific requirements.

Vipragen’s Research Team can conduct various in vitro and in vivo studies – efficacy studies for supplement claims and scientific evidence generation, it an also be used for Regulatory submission to various Health Authority (HA) to ensure compliance.

Functional food claims/nutrient claims /Food supplement health claims.

Claim Substantiation Using In Vitro /In vivo Models for Various Nutraceuticals

Nutraceuticals & Efficacy:

It’s important to note that nutraceuticals, while often perceived as natural and safe, can vary widely in terms of quality and efficacy. Companies/manufacturers should exercise caution and consult healthcare professionals before using nutraceutical products, especially to address specific health concerns or conditions. Additionally, the regulatory requirements for nutraceuticals can vary by country, so compliance with local regulations is essential.

Claim Substantiation:

Nutraceuticals & Efficacy:

In the current regulatory world and in view of advancements in scientific technology, it is required to demonstrate that the products (nutraceutical, cosmeceutical and nutricosmetics and all others in the segment) are proven to be efficacious and appropriate for the intended use through scientific studies.

Efficacy investigations are undertaken to validate product performance through the utilization of pertinent assays and models. The primary goal is to ascertain the degree of effectiveness achieved by the product and to substantiate its claims. For instance, a capsule designed to enhance immunity might be confirmed through a significant increase in cytokine secretion, an anti-aging cream could demonstrate improved skin health by augmenting collagen production in skin cells, or a mood enhancer could boost happiness by elevating serotonin production in neuronal cells etc...

Identify the Health Benefit: Define the specific health benefit or claim associated with the nutraceutical product. This could include improving heart health, boosting immune function, promoting joint health, or addressing a particular deficiency.

In Vitro Testing: Perform in vitro (laboratory) testing to assess the product’s potential mechanisms of action. This may include evaluating the antioxidant capacity, anti- inflammatory properties, or other relevant bioactivities of the ingredients.

Animal Studies: Conduct animal studies (preclinical trials) to assess the safety and efficacy of the nutraceutical. These studies help researchers understand how the product behaves in a living organism and whether it produces the desired effects without causing harm.

"Efficacy testing allows us to precisely measure the product’s performance, providing insights into its ability to effectively tackle the issue at hand. The goals to support product claims with strong and meaningful efficacy information."

Our Claim Substantiation Services:

We provide an extensive range of in vitro cell-based and biochemical efficacy models to validate claims for various products, such as cosmeceuticals and nutraceutical agents. These models offer valuable insights into the potential mechanisms by which these products interact with relevant targets, reinforcing and verifying their intended claims.

we offer a wide repertoire of in vitro cell-based or biochemical efficacy models for claim substantiation of a variety of products, including cosmeceutical or nutraceutical agents. These models provide an insight into the possible mechanistic action of the products on relevant targets that supports and confirms the intended claims.

In vitro cell based models, Efficacy, Safety and Claim studies

Dermatology Efficacy Models

  • » Skin Health
  • » Anti-aging
  • » Anti-wrinkle
  • » Skin Whitening
  • » Stretch Marks

Disease Conditions

  • » Psoriasis
  • » Acne
  • » Anti-wrinkle

Hair Growth Models

  • » Hair Growth Promotion
  • » Hair Growth Inhibition
  • » Scalp Health Promotion
  • » Hair Breakage and Attributes
  • » Hair Damage

At Vipragen Biosciences, we specialize in non-clinical regulatory services for a variety of agencies includes GRAS (USFDA), EFSA, MFDS-Korean FDA and India (FSSAI and Ayush).

Studies for Various Agencies

GRAS – USFDA

  • Systemic Toxicity Studies
  • » Acute Toxicity studies
  • » 14-day Repeated Dose Toxicity
  • » 90-day Repeated Dose Toxicity
  • Genotoxicity Studies
  • » AMES Test
  • » In vitro MNT/CAT
  • » In vivo MNT/CAT
  • Analytical Service Support
  • » HPLC
  • » MDV GC
  • » MDV
  • » Dose formulation analysis
  • Additional DARD Services
  • » RPDT
  • » Combined 28-Day + RPDT
  • » Segment I, II, III
  • » Extended one generation Toxicity

EFSA (EU)/MFDS

  • Systemic Toxicity Studies
  • » Acute Toxicity studies
  • » 14-day Repeated Dose Toxicity
  • » 90-day Repeated Dose Toxicity
  • Genotoxicity Studies
  • » AMES Test
  • » In vitro MNT
  • Analytical Service Support
  • » HPLC
  • » MDV GC
  • » MDV
  • » Dose formulation analysis
  • Additional DARD Services
  • » RPDT
  • » Combined 28-Day + RPDT
  • » Segment I, II, III
  • » Extended one generation Toxicity