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Consultation with respective government agency and expert guidance to the Client/Organization to complete licensing procedure. |
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Preparation of updated 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. |
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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. |
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Preparation of endorsement applications and notification of post approval changes including major or minor. |
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Frequent follow up of the CDSCO ( DCGI Office) & State FDA applications submitted and intimation of the status of pending cases |
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Arrange meetings/telecom between respective government agency and the Company as & when required. |
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Handling queries raised by respective authorities & assistance in providing appropriate response to the same by the Company. |
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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. |
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Regular intimation of the development of submitted application. |
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Updating for the new guidelines and changes if any in the current procedure or regulations. |
Types of Services
IND
An “investigational new drug (IND)” means a new chemical or biological entity or substance that has not been approved for marketing as a drug in any country. Investigational new drugs (IND) are subjected to investigation by sponsors to ascertain safety and pharmacological activity of the drugs in human beings in order to develop the products in on commercial scale.
NDA
New Drug Application (NDA) is an application required for every new drug which is intended to be marketed in a specific country for obtaining market authorization or approval from concerned authority. To gain this permission a sponsor submits preclinical and clinical test data for analyzing the drug information, description of manufacturing trials.
SNDA
A supplemental new drug approval (SNDA) is required when a manufacturer wants to make any changes in the drug which has already got approval through NDA.