Pharmaceutical & BioTech
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Dossier Development
MAA DOSSIER AND UPDATES
Marketing Authorization Application (MAA) dossiers may need to be created from raw data (e.g. CMC-related specifics, pre-clinical or clinical study reports), or, if existing, it may require adaptations or updates.
In both cases, RPN provides the right expertise and experience to pursuit the tailored solutions for the concerned product.
ABOUT THE CTD DOSSIER
The Common Technical Document (CTD) is a worldwide standard for the preparation of regulatory submissions for new pharmaceuticals. It defines the required content and structure of the Dossier, in support of a Marketing Authorization Application (MAA) for a medicinal product in the EU. RPN combines regulatory and scientific writing expertise for the creation of all CTD modules (see image).
PUBLISHING (eCTD)
RPN assists life science companies to streamline the entire submission process: from preparing eCTD-compliant files to publishing and submission.
With a team of qualified publishers and a state-of-the-art publishing software, RPN effectively and efficiently manages the specific local submissions globally.
The RPN publishing capabilities include:
- support in the identification of Regional/Local requirements;
- formatting of files and PDF rendition to eCTD compliant files;
- bookmarks and inter-document linking;
- technical validation;
- delivery of a technically compliant dossier in accordance with ICH Quality Guidelines and the different Regional Validation Criteria (e.g. EU, US, Canada, GCC);
- submission management: EMA Gateway, FDA Gateway, PSUR Repository, CESP, CD/Paper.