TMC Pharma Services Ltd (TMC) is a pharmaceutical development company that offers preclinical to post-marketing services and pharma/biotech services for human and veterinary medicines and devices. TMC covers disease areas such as rare and orphan diseases; advanced therapy investigational medicinal products covering stem cells and other cell-based therapies; and oncology, including biologics and immuno-oncology. The company provides preclinical support for data review, liaising with non-clinical pharmacology and toxicology units, and manufacturing/quality, including import release. TMC offers clinical trial management services comprising clinical project management, risk-based monitoring (RBM), data management and statistical analysis, trial master file (TMF) and eTMF services, and clinical trial site management. The company’s medical writers edit and write regulatory documents that consist of clinical trial applications (CTAs) such as investigational medicinal product dossiers (IMPD), marketing authorization application (MAA) dossiers, risk management plans (RMP), periodic safety update reports (PSUR), development safety update reports (DSUR), pediatric investigation plans, and orphan drug designation applications (ODD and OMPD).
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