Regulatory Affairs and Medical Writing
At CRNI we are equipped with a skilled team of medical writers carrying an experience in writing protocol, clinical trial design, and other study related documents. Regulatory team for ensuring focus on the right comprehensive regulatory solutions and expertise in achieving the regulatory approval and market access for the drug product. Our team function as a bridge and provides comprehensive and strategic services across the drug development and commercialization. With more than 8 years in pharma industry, team provides the strategic planning to arrive at an effective way of handling wide regulatory challenges across the trial. Our regulatory team assists in obtaining regulatory approvals for conducting Phase I to IV clinical trials, for new investigational drug, observational studies, and compilation of regulatory dossiers.