Prepare and support dossier submission for IND/NDA/ANDA/response to regulator queries/etc.
We prepare CTD reports all sourced modules to aid in regulatory submission. 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identification of relevant information, data mining, assessment of the reliability and quality of the published and unpublished dataset, extensive data-gap analysis, use of read-across, weight-of-evidence, and (Q)SAR, advising on appropriate Integrated Testing Strategies, study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 to handle large as well as small projects to consistently deliver to the committed deadline.