Regulatory Services


Whether your company is global or a start-up, we provide the help you need for faster access to local Markets and Opportunities. We help you succeed throughout the product Lifecycle :

Entellus Food & Drugs Regulatory Service is one of the reputed names, specialized in offering matchless Regulatory Services. We have expertise with all products and development activities regulated by Indian regulators. Our overall experience includes 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 team consist of former FDA officials & industry executives who have deep knowledge & More than 20 years of 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 and product development approvals.

 



Our Services Include

REGULATORY INTELLIGENCE REGULATORY STRATEGY REGULATORY SUBMISSIONS ON-DEMAND CONSULTING PROJECT MANAGEMENT
Product Specific Requirements Scientific & Regulatory  Assessment Preclinical & Clinical Development Plans Regulatory insight & Clarifications Project Management Plan
Periodic Regulatory Updates Product Development Plan Protocols, Investigator Brochures Strategies & Solutions Outsourcing - identify, manage, optimise
Precedents & Current thinking Regulatory Strategy & Roadmaps Dossier Preparation (For all kind of submissions)  Product Development Process optimisation Analyse & optimise performance
Product specific Status Document Risk Plans Review, Approvals, Maintenance Compliance Audit Services Education and training

Download

For more details please click on the links given below


Food Regulatory Services

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.

more...

Cosmetic Regulatory Services

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.


 

more...

Healthcare Regulatory Services

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.

more...

Pharmaceutical Regulatory Services

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.

more...

Contact Us

Entellus Food & Drugs Regulatory Services Pvt. Ltd.

B-30, Ground Floor, North Ex Mall, Sector-9, Rohini, Rohini, New Delhi - 110085, India

Mobile : +91-9999636195, +91-9871756830

E-mail : viphr999@gmail.com