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Regulatory Affairs
We prepare CTD reports from all sourced modules to aid in regulatory submissions. We provide detailed reports on the chemical/drug for supporting a large number of registration dossiers in a pragmatic, timely, and cost-efficient manner. We are also involved in all aspects of the registration process including identification of relevant information, data mining, assessment of the reliability and quality of the published and unpublished dataset, extensive data-gap analysis, use of read-across, weight of evidence, and (Q)SAR, advising on appropriate integrated testing strategies, study commissioning and monitoring (where needed), preparation of (robust) study summaries and associated endpoint summaries, completeness checks, interpretation and conclusion of the available data for submission. Our ability is to handle large as well as small projects to consistently deliver to the committed deadline.