Entellus Food & Drugs Regulatory Services Pvt. Ltd.

Rohini, Delhi

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. The India Agent has significant responsibilities and is also legally liable for the product in India. The extent of responsibility is very different from the role of the "US Agent" representative required by the United States FDA. The India Authorized Agent is granted, through Power of Attorney by the manufacturer, authorization to submit Product registration documents and act as a point of contact for any inquiries related to the Product by the CDSCO. The Agent is also involved in vigilance activities and acts on the manufacturer’s behalf if an onsite inspection of the manufacturer’s facility is required.

Entellus FDRS Pvt. Ltd. is the leading specialist HR Services (recruitment consultancy) to the Medical Devices, Diagnostics, Biological, Life Science, Vaccines, Pharmaceuticals, Advanced Therapeutics, Food & Neutraceuticals, Cosmetics, Generics & OTC and Veterinary Products, industry. Entellus was the first company of its kind to recognise the unique needs of the Healthcare, pharmaceutical, Cosmetics and food sector and to dedicate itself to exclusively serving those needs. Entellus has supported organisations in building high performance teams resulting in some of the most important innovations in recent years, bringing new discoveries to market. Run by medical and recruitment specialists, Entellus not only provides executive search and recruitment solutions, but also a range of bespoke consultancy services delivered by some of the industry’s leading thinkers. Entellus Today Today Entellus is in the nearly unique position of being able to offer a comprehensive suite of recruitment methodologies, customised to meet client needs. We also provide executive search solutions for critical board level positions, and use tested strategies with our extensive network of industry contacts to rapidly identify candidates for middle management roles. In all areas, Entellus takes the long view, seeking to build teams that will flourish and become self-sustaining, ensuring that the right talent is in place for future success. Many of our consultants have held senior posts in the industry and have a formidable track record of delivering complex recruitment assignments. They understand the importance of both competence and cultural fit and have access to high calibre, rare talent through our unrivalled and comprehensive networks. As recruitment models and expectations change, Entellus consultants are innovators who stand out from the crowd. Entellus continues to surpass industry expectations for quality, professionalism and innovation, delivering results that redefine industry standards.

The company is also a competent provider of Healthcare Regulatory Services for clients across the globe. The Healthcare Regulatory Services made available by the company can be availed at the best prices in the market, with proper quality assurance methods. The Healthcare Regulatory Services that we provide are handled by the most experienced and well-trained professionals. We also make sure that all the requirements are met, with the provision of our Healthcare Regulatory Services.   Scope of Work Study relevant regulations and consult with respective government agency and advice/ guide the Company to complete license process. Prepare dossiers for various applications like Drug/Device Registration certificate (Form- 41), Import license (Form-10), Test License (Form-11), New drugs (Form -45) , Clinical Trail Approval, BE NOC, Drugs Sales License (Form 20B & 21B), No Objection Certificate, Shelf Life Approval, Market standing certificate, No- Conviction Certificate etc. Provide assistance in the documents prepared by the company like covering letter, application forms like Form-  40, 44, 9, 12 etc, and schedule DI, DII, plant master file including manufacturing site plan and map, Drug/ Device Master file in general and other case specific documents. Preparing endorsement applications and notifications for post approval changes including major or minor. Regular follow up with the CDSCO ( DCGI Office) & State FDA applications submitted and status of cases pending with them. Facilitate communications / meetings between respective government agency & the Company as & when necessary. Handling queries raised by respective authorities & ensuring suitable replies to the same by the Company. Collect the cheque / pay order / banker cheque for deposit of related fee with Bank of Baroda, Kasturba Gandhi Marg, New Delhi or related banks in India. Latest updates on the development of submitted application. Will update for the new guidelines and changes if any in the current procedure or regulations.

The company makes available its Cosmetic Regulatory Services at the best prices in the market. These Cosmetic Regulatory Services are designed according to the requirements of clients. We make Cosmetic Regulatory Services available through the best and most experienced personnel. Also, our company makes sure of the fact that clients are maximally satisfied with the quality of the services made available to them. The company makes use of the most ethical and logical ways for the provision of these services.   Scope of Work Study relevant regulations and consult with respective government agency and advice/ guide the Company to complete registration processes Prepare dossiers for various applications as per regulations with the document like covering letter, Form-42, NOC, and Notification in general and other case specific documents. Provide assistance in the documents prepared by the company like schedule, DIII, Form -42, NOC, Notifications, plant master file including manufacturing site plan and map, product Master file in general and other case specific documents. Preparing notifications for post approval changes including major or minor. Regular follow up with respective government authorities for all documents submitted and status of cases pending with them. Facilitate communications / meetings between respective government agency & the Company as & when necessary. Handling queries raised by respective authorities & ensuring suitable replies to the same by the Company. Collect the cheque / pay order / banker cheque for deposit of related fee with Bank of Baroda, Kasturba Gandhi Marg, New Delhi. Entellus will inform up to date developments of submitted application. Entellus will update for the new guidelines and changes if any in the current procedure or regulations.  

The provision of Food Regulatory Services includes regulatory planning and assessment support for food, supplements, and animal feed products worldwide. The company makes available highly competent Food Regulatory Services. The Food Regulatory Services provided by us involve the task of identifying current global regulations for food products, including current ingredient approvals, labeling requiring and use of health claims. The company makes its Food Regulatory Services available through well-trained and experienced personnel. Also, these Food Regulatory Services are competitively priced in the market, with the assurance of complete satisfaction of clients.   Scope of work Study relevant regulations and consult with respective government agency and advice/ guide the Company to complete NOC / Registration/ license process. Provide assistance in the documents prepared by the company like covering letter, application form like A & B,    NOC Approval, registration  etc manufacturing site/Layout plan and map file in general and other case specific documents. Submit the application to FSSAI Office & Liaison work for Product Approval Regular follow up with respective government authorities whether of state or centre for the application submitted/Pending with them. Facilitate communications / meetings between respective government agency & the Company as & when necessary. Handling queries raised by respective authorities & ensuring suitable replies to the same by the Company. Latest updates on the development of submitted application. Will update for the new guidelines and changes if any in the current procedure or regulations.

We are efficient providers of Pharmaceutical Regulatory Services . The Pharmaceutical Regulatory Services made available by us can be availed at the best prices in the market, with proper quality assurance methods. Our company makes available its Pharmaceutical Regulatory Services with the assurance of maximum satisfaction for clients. Our company makes available its Pharmaceutical Regulatory Services using the most effective techniques and ethical methods.

we are service providers of regulatory services. i seek your attention on my proposal (a newsletter as follows) to consult you in regulatory affairs for india. if you want to enhance submission preparation and achieve faster product and product development approvals leading to enhanced access to markets and opportunities then we can help you to reach your goals please let us know if you are facing any problem in submission and product approval from cdsco (dcgi office). then entellus can be your choice entellus fdrs pvt. ltd. has established a name for itself in the field of regulatory affairs amongst the leading corporates. we have engaged with leading corporates dealing in medical devices, diagnostics, biological, vaccines, pharmaceuticals, advanced therapeutics, generics & otc, veterinary products, cosmetics, food & nutraceuticals etc. we have been serving corporates, across industries for their regulatory affairs matter by providing regulatory expertise and resources through all stages of product approvals. we welcome you to get in touch with us. our team consist of former fda officials & industry executives who have deep knowledge & experience in your industry, it moves beyond providing expert advice to get your project off the ground, move at a fast pace and achieve faster product approvals. handle preclinical, clinical trial approvals, product registrations, marketing authorizations, import and marketing authorizations, manufacturing and marketing authorization covering a large number of therapeutic and product categories. our services include: 1: regulatory intelligence 2: regulatory submissions 3: regulatory strategy 4: project management 5. independent representation in india

We are service providers of medical device registration services. I seek your attention on my proposal (a newsletter as follows) to consult you in regulatory affairs for india. If you want to enhance submission preparation and achieve faster product and product developmentapprovals leading to enhanced access to markets and opportunities then we can help you to reach your goals please let us know if you are facing any problem in submission and product approval from cdsco (dcgi office). Then entellus can be your choice entellus fdrs pvt. Ltd. Has established a name for itself in the field of regulatory affairs amongst the leading corporates. We have engaged with leading corporates dealing in medical devices, diagnostics, biological, vaccines, pharmaceuticals, advanced therapeutics, generics & otc, veterinary products, cosmetics, food & nutraceuticals etc. We have been serving corporates, across industries for their regulatory affairs matter by providing regulatory expertise and resources through all stages of product approvals. We welcome you to get in touch with us. our team consist of former fda officials & industry executives who have deep knowledge & experience in your industry, it moves beyond providing expert advice to get your project off the ground, move at a fast pace and achieve faster product approvals. Our services include: 1: regulatory intelligence 2: regulatory submissions 3: regulatory strategy 4: project management 5. Independent representation in india for any clarification please feel free to contact. Entellus is looking forward to serve you in best way