QUALITY ASSURANCE STRATEGY
Introduction: The Clinical Quality Assurance has witnessed a dramatic rise in its impact and effectiveness in the drug development and clinical research. The first applications of quality assurance to the drug development , pre-clinical studies , and clinical research have been explored from the day of its infancy ,by a handful of drug pioneers. Quality assurance has been integrated with all the phases of clinical research and drug development.
Practical Knowledge of Regulatory Guidelines for E-Drug Marketing Applications Makes for Smooth Submissions.
One of our clients wanted to submit electronic Abbreviated New Drug Application (ANDA) to USA FDA, to get market approval for a generic drug. We prepared the entire ANDA in electronic Common Technical Document (eCTD) XML format.
Initiation of a multi-center Phase III clinical study in India within 60 days
Customer Profile : A large MNC pharmaceutical company approached MakroCare to initiate and conduct a multi-center clinical study in India. The study contained a very complex protocol. Earliest initiation of study is the key factor for a successful outcome.
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