The fast lane of your regulatory submissions …
Recently, the regulatory environment in Canada and internationally has seen the emergence of new electronic business rules. Specifically, it is a matter of regulating the way pharmaceutical companies submit their dossiers to regulatory authorities for marketing authorization. Several electronic formats are currently available. The main format is the eCTD for “electronic Common Technical Document”, which is the electronic version of the CTD. The eCTD format is currently either preferred or required by Health Canada, the US FDA, the EMA in Europe and other regulatory agencies. In addition, Health Canada and the US FDA have also offered the opportunity to submit regulatory files via the Internet through a secure connection using digital certificates issued according to high security standards.
The requirements governing both the submission compilation and filing are technically demanding and constantly evolving. Thus, the pharmaceutical industry, and in order to adequately meet the electronic regulatory requirements and avoid any submission delays or business impacts due to these regulations, need to be assisted and supported by an experienced and knowledgeable service providers.
Based in Montreal, Canada, eCTD Now is a company fully dedicated to support the pharmaceutical industry in all aspects related to the electronic regulatory submissions. We are committed to delivering the highest quality first time ensuring efficient processing of your eCTD transactions by the regulatory agencies.
2860, rue Lafrance Montréal, QC H4R 1H3
(+1) 514 623-4257