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About Us
Essphar is a multi disciplinary firm that are specializing in the pharmaceutical products development, Analytical support like method development and method validation
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Our Leadership Team
Mr. Sanjay nayak
Business Head
Products & Services
Pharmaceutical
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Pharmaceutical
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Specifications
Regulatory affairs
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Regulatory affairs
As you might be aware of a couple of European Systems for obtaining the marketing authorization of medicines in Europe "The Centralized Procedure" via EMA valid throughout Europe. The Nationalized ProceduresDecentralized Procedure and Mutual Recognition procedures(EMEA) as per procedure is laid down in EU Directive 2001/83/EC and 2004/27/EC are the routine tasks for us. And most of the MRP applications have closed out with a positive approval at day 90 and DCP's at Day 120 means in Assessment Step 1.
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Co product development proposal
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Co product development proposal
essphar focuses on developing and manufacturing niche generic formulations, and a leading provider of affordable, life-enhancing generic pharmaceutical products persevered to the highest quality standards. We are willing to strive as a co-development partner with the MA holder for the generic product development and, therefore, can jointly commercialize pharmaceutical products worldwide.
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Clinical bioequivalence study management
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Clinical bioequivalence study management
Our In-House expert with in-depth experience about the understanding of the molecule and technical input facilitates the Clinical Centers (CRO) to establish robust bioequivalence study protocols. Our connectivity within the CRO community is widespread and efficient.
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Produc development Services
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Produc development Services
Intellectual Property Evaluation (IP related issues & Final IP clearance for drug substances (from attorney), Drug Product related IP landscape, Final IP clearance for drug product (from attorney)
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Pharmacovigilance
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Pharmacovigilance
Qualified Person for Pharmacovigilance (QPPV) / Pharmacovigilance Officer In-charge (PvOI).
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Medical writing
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Medical writing
Medical and Scientific Literature Reviews
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