| > | Consultation with respective government agency and expert guidance to the Client/Organization to complete licensing procedure. |
|---|---|
| > | Preparation of updated dossiers for various applications like Drug 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, Non Conviction Certificate etc. |
| > | Assistance to the company in edition and documentation requirements like cover 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. |
| > | Preparation of endorsement applications and notification of post approval changes including major or minor. |
| > | Frequent follow up of the CDSCO ( DCGI Office) & State FDA applications submitted and intimation of the status of pending cases. |
| > | Arrange meetings/telecom between respective government agency and the Company as & when required. |
| > | Handling queries raised by respective authorities & assistance in providing appropriate response to the same by the Company. |
| > | Collection of the cheque / pay order / banker cheque for deposition of related fee with Bank of Baroda, Kasturba Gandhi Marg, New Delhi or related banks in India. |
| > | Regular intimation of the development of submitted application. |
| > | Updating of the documents as per new guidelines and changes, if any, in the current procedure or regulations. |