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DEPARTMENTS WE CATER
The Central Drugs Standard Control Organization (CDSCO) is a regulatory body that lays down stringent standards that any drug, medical devices, diagnostic kits, cosmetics, biologicals and vaccines being introduced into the country must meet before being sold in the market.
The State Food and Drug Administration has branches in every state that serve to maintain safety and quality standards of food ingredients, food products and imported drugs. This is the highest governing authority for all food and drug clearances needing entry into the country and every state.
CDSCO has 6 Zonal Offices which are headed by Dy. Drugs Controller (India). These have several responsibilities including Grant or renewal of manufacturing licenses for Vaccine, LVP, Bio-Tech/Biosimilar products, and Medical Devices, Approval of Institution for carrying out Test on Drugs, Cosmetics and Raw materials, Approval BA/BE studies and Clinical Trial site, Grant or revalidation of COPPs, Issuance of COPPs for additional products and any other inspection communicated from the Office of the DCGI.
The Indian Council of Medical Research (ICMR) essays a vital role in the prevention and control of communicable diseases, research regarding toxicology, immunology, reproduction, national medical statistics, food standards and other primary health topics of national interest. It is the leading body regulating all medical research in the country.
The Food Safety and Standards Authority of India (FSSAI) is a branch of the Ministry of Health and Family Welfare dedicated to standardizing food products made available in the market through a series of stringent standards that ensure food safety. They ensure only the highest quality of foods are made available to the public.
We provide full spectrum of regulatory services to companies all over the world trying to venture in the Indian market. We have considerable industry knowledge in the food sector to assist international business owners doing business in India who are subject to the food regulatory authority in India.
Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for drugs, control over the quality of imported drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view to bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.