Regulatory Dossier submission and
Scientific Writing Services
We at Adept develop, review, assess and file the dossier of diverse pharmaceutical products (NCE, NDA and ANDA) containing its detailed data (administrative, chemistry, preclinical & clinical) for product licensing in the ICH region and India. Our expert teams are capable of Developing DMF, CTD (All modules) and e-CTD for timely filing of the dossier to the concerned regulatory authority around the globe. We also take up projects for filing to national agencies like CDSCO and DCA (All States).
We take up writing services like Medical and Regulatory writing. We provide data Analysis and review services. The clinical study data is being reviewed and analyze by our highly qualified and experienced team of Medical and scientific writers.