Monitoring Bioequivalence Studies Services

Navi Mumbai, 400710
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+91 2 266 735 877

We provide consulting & complete project management services to generic pharmaceutical companies for Bioequivalence and related activities. We have been supporting Generic Pharmaceutical companies in Product feasibility assessment, CRO selection, Medical writing, Project management for BE study, BE study monitoring, Failed BE study analysis, IVIVC and Regulatory support regarding BE studies.

 

Our strength is our technically sound team who have been constantly delivering the projects within time. We provide a deep insight to your generic product development and ensure a risk mitigation strategy is in place for bioequivalence program to save millions of dollars for your organisation.

 

With 25+ experienced & qualified team of Project Managers, Clinicians, Pharmacologists, Formulators, QA, Regulatory, Analytical, Bioanalytical experts as well as Ex—MHRA Consultant on Board, Pharmadesk takes complete ownership of your Bioequivalence studies and ensures they get completed efficiently & successfully by carefully evaluated & selected CROs in India.

 

With an experience of handling more than 380 successful BE studies submitted to EU and USFDA regulatory authorities and based on the cumulative experience of multiple products for multiple markets, we have well-defined processes in place for every activity in the Bioequivalence study cycle. We assign a dedicated project manager for every project to ensure complete attention is given to individual projects.

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