Enabling short-term, quality assured and ICH compliant implementation of regulatory information documents in CTD (Common Technical Document) and in eCTD (electronic CTD) format, BiRDS Pharma AG offers the preparation of submission documentation from our clients regulatory information documents. This includes creating eCTD submissions from clients dossiers, converting of parts or of full dossiers to the eCTD-format, compiling electronic submission on the basis of paper or mixed documentation, checking and validation of eCTDs, and conversion of old European NTA-format submission to CTD. As a technical service, BiRDS Pharma AG offers automatic generation of XML standard backbone and transmission according to the ICH eCTD specification, preparation for submission on CD or DVD. |
