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Entellus Food & Drugs Regulatory Services Pvt. Ltd.

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.


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