intuitivepharma.com

Intuitive Pharma: Welcome To IntuitivePharma

Intuitive Pharma provides premium consultancy services to pharmaceutical companies in domains of biopharmaceutics, bioequivalence and Regulatory support. The services include but not limited to, Pharmacokinetic Modeling & Analysis, Formulation Optimization, Dissolution Media Identification, IVIVC, CRO Identification, Site Audit, Monitoring, Protocol Design & Development, Report Review, Pharmacokinetic & Biostatistics Analysis, Regulatory support towards query resolution

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Intuitive Pharma: Welcome To IntuitivePharma | intuitivepharma.com Reviews

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Intuitive Pharma provides premium consultancy services to pharmaceutical companies in domains of biopharmaceutics, bioequivalence and Regulatory support. The services include but not limited to, Pharmacokinetic Modeling & Analysis, Formulation Optimization, Dissolution Media Identification, IVIVC, CRO Identification, Site Audit, Monitoring, Protocol Design & Development, Report Review, Pharmacokinetic & Biostatistics Analysis, Regulatory support towards query resolution

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Intuitive Pharma: Welcome To IntuitivePharma | intuitivepharma.com Reviews

https://intuitivepharma.com

Intuitive Pharma provides premium consultancy services to pharmaceutical companies in domains of biopharmaceutics, bioequivalence and Regulatory support. The services include but not limited to, Pharmacokinetic Modeling & Analysis, Formulation Optimization, Dissolution Media Identification, IVIVC, CRO Identification, Site Audit, Monitoring, Protocol Design & Development, Report Review, Pharmacokinetic & Biostatistics Analysis, Regulatory support towards query resolution

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intuitivepharma.com

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Blog - Intuitive Pharma

http://www.intuitivepharma.com/index.html

Documents to be submitted to DCGI for grant of BA / BE NOC – Updated FEB 2014. Monday, February 10, 2014. Posted by Analyst IP. DCGI has revised the list of documents that needs to be submitted for grant of DCGI BA / BE NOC. This will be effective from 01st February 2014. This article provides the micro details of the updated list of documents required by DCGI for grant of BA / BE NOC. A: Approved in India for more than 4 years except for modified release dosage form [old drugs]. Form-12 application alon...

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Intuitive Pharma: Site Map

http://www.intuitivepharma.com/p/site-map.html

Subscribe in a reader. Documents to be submitted to DCGI for grant of BA / BE NOC – Updated FEB 2014. Documents to be submitted to DCGI for grant of BE NOC. Revised list of documents to be submitted to DCGI for grant of BA / BE NOC - Updated JAN-2014. Notification to DCGI regarding amendment to approved protocol. How to get DCGI NOC without query. Submission of additional bioequivalence study Data for ANDAs - New FDA Requirment. 169; Intuitive Pharma.

3

Documents to be submitted to DCGI for grant of BA / BE NOC – Updated FEB 2014 - Intuitive Pharma

http://www.intuitivepharma.com/2014/02/Documents-to-be-submitted-to-DCGI-for-grant-of-BA-BE-NOC-Updated-FEB-2014.html

Documents to be submitted to DCGI for grant of BA / BE NOC – Updated FEB 2014. Monday, February 10, 2014. Posted by Analyst IP. DCGI has revised the list of documents that needs to be submitted for grant of DCGI BA / BE NOC. This will be effective from 01st February 2014. This article provides the micro details of the updated list of documents required by DCGI for grant of BA / BE NOC. A: Approved in India for more than 4 years except for modified release dosage form [old drugs]. Form-12 application alon...

4

How to get DCGI NOC without query - Intuitive Pharma

http://www.intuitivepharma.com/2011/07/how-to-get-dcgi-noc-without-query.html

How to get DCGI NOC without query. Saturday, July 30, 2011. Posted by Analyst IP. Though no official guidelines have been published CROs and Sponsors have been receiving deficiency letters from DCGI. We depict some important points to be kept in mind while drafting protocols, ICF for clinical trials and the supportive documents that should be provided along with DCGI NOC application so as to obtain DCGI NOC without queries. Study Related Injury and Compensation:. The onus on study related injury will be ...

5

Documents to be submitted to DCGI for grant of BE NOC - Intuitive Pharma

http://www.intuitivepharma.com/2010/10/documents-submit-dcgi-be-noc-export.html

Documents to be submitted to DCGI for grant of BE NOC. Saturday, October 02, 2010. Posted by Analyst IP. The documents required for DCGI No Objection Certificate (DCGI BE NOC) for conducting a biostudy in India are general in nature, however depending on the nature of the drug,disease and studies further specific information may also be required to be furnished by the firm. For the revised list of documents required for grant of DCGI BA / BE NOC. The treasury challan will cost Rs. 15000/. Undertaking by ...

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Intuitive Pharma: Welcome To IntuitivePharma

We extend premium consultancy solutions to pharmaceutical companies. Our domain of expertise includes biopharmaceutical [inclusive of but not limited to Pharmacokinetic Modeling, Formulation Optimization, Dissolution Media Identification. IVIVC], bioequivalence/bioavailability [inclusive of but not limited to CRO Identification, Site Audit, Biostudy Monitoring, Protocol Design and Development, Report Review, Pharmacokinetic and Biostatistics Analysis]and regulatory support towards queries. Yo...Documents...

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