Herbal Consultants Pvt. Ltd. has the expertise to guide you in designing research strategies to study the quality, safety, and efficacy of your products. We can also coordinate the entire research process from start to finish in areas such as:
- Preclinical Research.
- Clinical Research.
- Analytical and Specialty Research.
- Individual GAP analysis of the available safety data for your product.
- Conceptualization of in vitro and animal studies with GLP certified laboratories to determine the safety of your product.
- Compilation of suitable data sheets (COA, shelf life, microbiological activity, allergens, non-GMO, pesticides, MSDS).
- Product-suitable safety and marketability assessments by certificated experts, which fulfill the latest corresponding national requirements.
Food products and food ingredients (plant extracts, flavorings and additives) must comply with the respective food law provisions of the target market, including general requirements for food safety to protect consumer’s health, such as:
- Department of AYUSH, FSSAI and FDA, India.
- European communities: Regulation (EC) No 178/2002.
- USA: Dietary Supplement Health and Education Act (DSHEA), Federal Food, Drug, and Cosmetic Act (FD&C Act), GRAS.
To ensure the legal distribution status of food products and ingredients and to increase the capacity to compete on the international food markets, we advise to compile sufficient scientific documents to document the safety of your product prior the market entry.
With years of experience in study design, protocol development, data management, and statistical analysis, we also specialize in utilizing novel and cutting-edge research techniques and product-specific customized assays. We can help you optimize your research dollars to establish a record of safety and efficacy for your products with study designs that give you the most pragmatic, market-ready information.
The elements of a proper clinical trial include power analysis, protocol design, Institutional Review Board (IRB) or Ethics Committee (EC) approval, recruitment of study subjects, statistical analysis of the data by a competent biostatistician and sound interpretation and presentation of the results. Conducting properly designed clinical trials is a forward-thinking investment that can help:
- Provide a solid basis to support claim substantiation.
- Help distinguish your products from the competition.
- Make a statement about your company’s dedication to evidence-based natural products.
- Can be submitted for publication in peer-reviewed scientific journals.