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WELCOME TO PHARMANTRA SERVICES

Excellence is doing ordinary things extraordinarily well. John W. Gardner. To accelerate global drug development through expert regulatory collaboration. To become the preferred partner for regulatory strategy and execution for drug development companies worldwide.

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Ranjani Nellore

502 Apa●●●●●●●ts - II

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Hyd●●●bad , Andhra Pradesh, 500084

India

91.9●●●●2225
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Ranjani Nellore

502 Apa●●●●●●●ts - II

Kon●●●pur

Hyd●●●bad , Andhra Pradesh, 500084

India

91.9●●●●2225
ra●●●●●●●●●●●●@yahoo.com

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PharMantra

Ranjani Nellore

502 Apa●●●●●●●ts - II

Kon●●●pur

Hyd●●●bad , Andhra Pradesh, 500084

India

91.9●●●●2225
ra●●●●●●●●●●●●@yahoo.com

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WELCOME TO PHARMANTRA SERVICES | pharmantra.com Reviews
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Excellence is doing ordinary things extraordinarily well. John W. Gardner. To accelerate global drug development through expert regulatory collaboration. To become the preferred partner for regulatory strategy and execution for drug development companies worldwide.
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3 sample projects
4 resources
5 why choose us
6 company overview
7 philosophy
8 purpose
9 vision
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WELCOME TO PHARMANTRA SERVICES | pharmantra.com Reviews

https://pharmantra.com

Excellence is doing ordinary things extraordinarily well. John W. Gardner. To accelerate global drug development through expert regulatory collaboration. To become the preferred partner for regulatory strategy and execution for drug development companies worldwide.

INTERNAL PAGES

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1

WELCOME TO PHARMANTRA SERVICES

http://www.pharmantra.com/sampleprojects.html

Strategic advice and operational assistance. Small and mid-size US companies. Outsourcing manufacturing and preclinical testing activities; audits and project oversight. Academic labs and individual investigators. Interacting with regulatory agencies, responding to queries, documentation support. Some of our projects. Managed transfer to India for all CMC activities for an NCE molecule for virtual company with an US IND; submitted IND amendments. Compiled investigator IND and IMPD for EU submissions.

2

WELCOME TO PHARMANTRA SERVICES

http://www.pharmantra.com/aboutus.html

Founder - Ranjani Nellore, Ph.D., RAC. Ranjani is a pharmaceutical scientist with 15 years of experience in the US and Indian pharmaceutical industry. She has hands-on experience of drug development for new chemical entities (NCEs) in various therapeutic areas. With a proven track record of setting up departments in large companies, she founded PharMantra in January 2008 to bring her global drug development expertise to assist companies interested in leveraging the India advantage. Eswari Muthukrishnan i...

3

WELCOME TO PHARMANTRA SERVICES

http://www.pharmantra.com/resources.html

Some useful external websites. US Food and Drug Administration (FDA). European Agency for the Evaluation of Medicinal Products. Therapeutic Goods Administration (Australia). Medicines and Healthcare Products Regulatory Agency (UK). Central Drugs Standard Control organization (India). International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH, Geneva). Clinical Trials Registry (US). National Institutes of Health. Links for Indian regulations.

4

WELCOME TO PHARMANTRA SERVICES

http://www.pharmantra.com/whychooseus.html

PharMantra services are provided by highly qualified professionals. With hands on industry experience and proven track record. PharMantra serves each client on a priority basis and executes each project in time. PharMantra is committed to excellence and works professionally with each client in a collaborative spirit to enable high quality deliverables. Leveraging the India Advantage :.

5

WELCOME TO PHARMANTRA SERVICES

http://www.pharmantra.com/services.html

Interface with regulatory agencies. Technical evaluation of vendors, service providers. Evaluation and audits of manufacturing facilities. Interface with regulatory agencies. Regulatory submissions INDs, IMPDs, QOS. Documentation SOPs, reports. Nonclinical PK/TK/ADME and Clinical Pharmacology. Preclinical and Clinical PK Analysis using WinNonlin and Reporting. Prestudy Audits and Monitoring of preclinical studies for Regulatory Toxicology Studies conducted in India (OECD and FDA GLP). EU CTAs; IMPDs, CTD.

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Excellence is doing ordinary things extraordinarily well. John W. Gardner. To accelerate global drug development through expert regulatory collaboration. To become the preferred partner for regulatory strategy and execution for drug development companies worldwide.

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