Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 6, Issue 1, 2019

Background: The healthcare is a highly regulated sector as it serves billions of population globally. The two imperative pillars of this sector are pharmaceutical industry and health regulatory authorities. While the industry acts as a supplier in this sector, regulators provide governance to ensure quality, safety and efficacy of the healthcare products. Even though organizational objectives of these two stakeholders are diffe Read More

Background: The role of various probiotic microorganisms with a particular emphasis on their therapeutic use in human health and disease has been highlighted by diverse scientific research reports. Due to improvement and introduction of new technologies useful to understand the functionality and mode of action of probiotics with respect to nutritional as well as health perspectives, the research on probiotics has re Read More

Background: Hair care cosmetics are meant for the purpose of cleansing, modifying, promoting growth and grooming the hair. These products are designed to provide nourishment and prevent hair damage; these are mainly comprised of shampoos, conditioners, grooming products, etc. The products have gained prominent deliberations across the globe due to increasing issues of hair related problems. As these problems are Read More

Introduction: Nutraceuticals although is a widely accepted term and now well understood, there exists several nomenclature and definitions across the countries. The present article discussed the progression of Indian food product regulations over the years, mainly emphasizing on regulations of nutraceuticals and dietary supplements. Regulatory Progression in India: The regulatory structure of nutraceuticals in India has evolved Read More

Background: The product registration in rest of the world is a challenging task because they are not harmonized. ASEAN and GCC regions come under semi-regulated market. These regions have somewhat harmonized their regulatory organization. The significance of an emerging market is increasing globally. It is important for pharmaceutical companies to be up-to-date with the latest regulatory development. ASEAN used A Read More