Entellus Food & Drugs Regulatory Services Pvt. Ltd.

Rohini, Delhi

Entellus Food & Drugs Regulatory Service have expertise with all products and development activities regulated by Indian regulators. Our team consist of former FDA officials & industry executives who have deep knowledge & More than 20 years of experience in your industry.

Entellus Food & Drugs Regulatory Service specializes in providing customers with expert regulatory solutions for the development of Therapeutics, Medical Technology, Vaccines, Cosmetics and Food based Products in India. We provide Regulatory, Product Development expertise and resources through all stages of product development to enhance submission preparation and achieve faster product approvals leading to enhanced access to Markets and Opportunities.

Entellus Food & Drugs Regulatory Service has established a name for itself and earned adamant trust in the field of regulatory affairs amongst the leading corporations. Our team consists of former FDA Officials & executives who have deep knowledge & experience in the healthcare industry. It goes beyond providing expert advice by helping your project move at fast pace and achieve faster product approval.

Thus, we are able to provide regulatory expertise to the manufacturers and importers of Healthcare Industry by diluting regulatory barriers at all stages of product development leading to quick access to markets and opportunities through enhanced pace of submission preparations.

Industry Focus :
Medical Devices, Cosmetics, Diagnostics, Biologicals, Vaccines, Pharmaceuticals, Advanced Therapeutics, Generics & OTC, Veterinary Products, Food & Nutraceuticals.

Independent Representation/Authorized Agent for Medical Devices : India Authorized Agent Representative for medical device Companies Entellus Food & Drugs Regulatory Service representing medical device companies with no registered location in India must appoint an agent responsible for pre-certification and post-market surveillance inquiries. The Indian Agent must be a resident of India OR maintain a place of business there. Our office in Delhi (India), Entellus FDRS Pvt. Ltd. can act as your India Authorized Agent. Responsibilities of the India Authorized Agent representative The India Authorized Agent is a person/company responsible for Product registrations, acting as the liaison between the manufacturer and the CDSCO (Central Drugs Standard Control Organization). Foreign manufacturers of Products that are on the list of regulated products must appoint an Indian Authorized Agent.