Pharmaceutical regulatory consultants form the quintessence of the new Indian pharmaceutical industry recognized and thus counted among the biggest and fastest-growing markets in the world. Such consultants are qualitatively armed with expertise in detailing the complex regulatory guidelines that surround the formulation and manufacturing as well as marketing of drugs. The dramatic range of Indian pharmaceutical firms from multinationals to small-scale manufacturers calls for the utmost adherence to both national and international regulations in this country. As the Indian pharmaceuticals industry is under the purview of CDSCO responsible for new drugs approvals and clinical trials, regulatory consultants guide companies through the sometimes sophisticated processes of getting approval, especially ensuring that all the documentation, such as drug submission and clinical trial applications are appropriately prepared. Their knowledge ensures that businesses are updated on the subtleties of the Drugs and Cosmetics Act and rules and guidelines pertinent to it, thus enabling them to avoid any potential setbacks on regulatory grounds that may risk the launch of their product or add heavy penalties to their account.

Their expertise is much wider than mere compliance; they often act as a kind of interface between pharmaceutical companies and the regulatory authorities. When consultants develop clear communication and understanding with...