Regulatory Operations

We are able to help pharma companies prepare for e-submissions (including non-eCTDs and eCTDs) by advising on:

  • The adoption of processes for first-time-right authoring and publishing

  • Implementation of a standardized document or content management system

  • Implications of and best practice for document/dossier lifecycle management

  • Dossier project management of MAAs and major variations

  • Coordination with Regulatory Agencies on technical issues related to eCTD submissions

Qdossier services

Lean publishing of regulatory documents

  • Managing scanning and conversion to PDF

  • eCTD readiness of documents, including paper and scanned images

Compiling, hosting and maintenance of eCTDs, non-eCTD electronic submissions (NEESs) and ASEAN-CTDs

  • Assembly of electronic and paper dossiers

  • Electronic hosting of regulatory dossiers on our dedicated server

  • Burning CDs/DVDs and printing of labels

  • Ensuring that the dossiers can be printed anywhere in the world by preparation of print files for paper output

  • Coordination of dispatch of CDs/DVDs and/or paper dossiers

Preparation of baseline submissions

  • Ensuring the right level of granularity is applied. This optimizes re-use of documentation across multiple regions and impacts your submission maintenance.

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