Regulatory Consultancy
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Products are an evolving market and many companies in the sector are unfamiliar with clinical trials requirements. We offer clinical trials a unique set of challenges compared with pharmaceutical counterparts; however, the guiding principles of robust design, effective data capture and expert data analysis sphere true in both industries.
We are offering sole consultancy to your product development to marketing. NovoBliss can provide you current market and consumer insights, by understanding the initial concept of your product development to seeing tangible finished products in the market by delivering up-to-date, efficient and approved processes for you throughout our business relationship. We can guide you scientific study design per your product vision, help you to create research path understanding your budget capacity to spend.
Products are an evolving market and many companies in the sector are unfamiliar with clinical trials requirements. We offer clinical trials a unique set of challenges compared with pharmaceutical counterparts; however, the guiding principles of robust design, effective data capture and expert data analysis sphere true in both industries.
We are offering sole consultancy to your product development to marketing. NovoBliss can provide you current market and consumer insights, by understanding the initial concept of your product development to seeing tangible finished products in the market by delivering up-to-date, efficient and approved processes for you throughout our business relationship. We can guide you scientific study design per your product vision, help you to create research path understanding your budget capacity to spend.
Products are an evolving market and many companies in the sector are unfamiliar with clinical trials requirements. We offer clinical trials a unique set of challenges compared with pharmaceutical counterparts; however, the guiding principles of robust design, effective data capture and expert data analysis sphere true in both industries.
We are offering sole consultancy to your product development to marketing. NovoBliss can provide you current market and consumer insights, by understanding the initial concept of your product development to seeing tangible finished products in the market by delivering up-to-date, efficient and approved processes for you throughout our business relationship. We can guide you scientific study design per your product vision, help you to create research path understanding your budget capacity to spend.
Products are an evolving market and many companies in the sector are unfamiliar with clinical trials requirements. We offer clinical trials a unique set of challenges compared with pharmaceutical counterparts; however, the guiding principles of robust design, effective data capture and expert data analysis sphere true in both industries.
We are offering sole consultancy to your product development to marketing. NovoBliss can provide you current market and consumer insights, by understanding the initial concept of your product development to seeing tangible finished products in the market by delivering up-to-date, efficient and approved processes for you throughout our business relationship. We can guide you scientific study design per your product vision, help you to create research path understanding your budget capacity to spend.
Products are an evolving market and many companies in the sector are unfamiliar with clinical trials requirements. We offer clinical trials a unique set of challenges compared with pharmaceutical counterparts; however, the guiding principles of robust design, effective data capture and expert data analysis sphere true in both industries.
We are offering sole consultancy to your product development to marketing. NovoBliss can provide you current market and consumer insights, by understanding the initial concept of your product development to seeing tangible finished products in the market by delivering up-to-date, efficient and approved processes for you throughout our business relationship. We can guide you scientific study design per your product vision, help you to create research path understanding your budget capacity to spend.
Challenges in Nutraceuticals and Food Trials:
- Regulatory awareness
- How to claims and what to claims?
- Larger sample sizes
- Very difficult to pick an endpoints
- Often a need to do a pilot study to enhance insight into desired end results
- Harder to recruit for and have higher drop-out rates than pharmaceutical trials
Nutraceuticals | Functional Foods
Food products are consumed for a feeding purpose or for the benefit of health maintenance and wellbeing. They are composed of nutrients (such as proteins, carbohydrates, fats, fibres, sodium, vitamins and minerals) and/or of other substances with a nutritional or physiological effect, such as botanical substances.
Nutraceuticals are specialized food products specially formulated in view of fulfilling specific nutritional or physiological purposes. Some are specifically formulated to meet the needs of specific population groups. Others, based on a specific formulation or on demonstrated effect(s), they can claim their particular characteristics through nutrition and health claims. Foods can provide non-therapeutic health benefits such as reduction of a risk factor in the development of a disease or significant content of a substance related to the growth, development and normal functions of the body. Some categories of Nutraceuticals belong to dedicated regulatory statuses such as dietary/food supplements, foods for special medical purposes (= Medicinal Foods) or foods for specific populations such as infants.
Key challenges encompass
- Determination of eligible & appropriate regulatory status (Supplement, Medical food, functional food with health claims), justification towards national and international authorities;
- Establishing safety of New Ingredients and Novel Foods;
- Design of clinical trials to support new health claims
- Define claims eligibility, extent and wording;
Solutions
Science-based, global product development strategy and planning
- Identify path to the market and pertinent regulatory requirements
- Define optimal regulatory strategy for successful international market entry taking into consideration potential different regulatory requirements depending on targeted local markets
- Ensure compliant strategies for labeling and promotion materials
- Prepare and submit applications and notification dossiers in key global markets
Nonclinical and Clinical Development
- Define appropriate clinical development program
- Correct definition of study population and clinical endpoints
- Assist with protocol design for human studies
- Determine appropriate nutrition and health claims development strategies